August Newsletter 2022

EUROPEAN UNION (EU)

MDCG guidance on Notified body capacity and availability of medical devices and IVDs |26 August 2022

The MDCG acknowledges that there are still significant and urgent challenges to be overcome to ensure that manufacturers are prepared and that notified bodies have enough capacity to certify medical devices and in vitro diagnostic medical devices following the EU MDR and the IVDR within the transition periods specified in the Regulations. According to the information acquired thus far, there are several causes, and a variety of solutions are needed.

MDCG lists some measures to increase the capacity of the informed body manufacturers’ readiness and access to notified bodies to facilitate the transition to the MDR and IVDR and to prevent a medical device shortage. Some of the points mentioned in the guidance are listed below:

  • Use of hybrid audits
  • The utilisation of a framework for evidence from previous assessments under the directives to prevent any duplication of work
  • Combining audits under directives and MDR/IVDR for Surveillance of legacy devices and focussing on the compliance of requirements set out by MDR/IVDR
  • Standard fees of notified bodies to be made available for public
  • Schemes for Small-to-medium enterprise manufacturers and first-time applicants

Expert decision and opinion on CECP|24 August 2022

Expert decision and opinion of the Clinical Evaluation Consultation Procedure (CECP) of tricuspid valve replacement system in the latest announcement released by the European Commission. As per the document, notified bodies are required to consider the opinions expressed in the scientific opinion of the expert panel, particularly when those experts find the level of clinical evidence to be insufficient or have significant reservations about how to balance benefits and risks, whether the clinical evidence is consistent with the intended use, including any medical indications, or with the post-market clinical follow-up (PMCF) plan.

Public consultation on reclassification of products without an intended medical purpose |11 August 2022

EU regulations on medical devices cover products without a medical purpose. For a complete list, see Annex XVI to Regulation (EU) 2017/745. Examples include laser or intense pulsed light devices for hair removal or skin treatment, liposuction tools, and brain stimulation devices.

As a result of this initiative, such devices will be subject to the same pre- and post-market regulations as comparable medical devices and will be classified following their risks. The commission encourages the public to give feedback on this initiative. More information on the consultation can be found here.

The consultation is open until the 08th of September 2022.

MDCG guidance on designation, re-assessment and notification of conformity assessment bodies and notified bodies| 10 August 2022

This document is intended to guide the authorities in charge of notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting assessments of conformity assessment bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and in vitro diagnostic medical devices, and ii. re-assessments of NBs.

Furthermore, this guide is intended to bring consistency and alignment to the working practices of the various designating authorities in the Member States in terms of CAB and NB assessment, designation, notification, and re-assessment.

European Commission publishes calls for European Union Reference Laboratories for IVDs designation| 05 August 2022

The European Commission has issued a call for Member States to submit applications on behalf of candidate EU Reference Laboratories for IVDs (EURLs). EURLs will be critical in batch testing and verifying the performance of high-risk (Class D) in vitro diagnostic medical devices (IVDs).

CZECH REPUBLIC

Seminar on Obligations of manufacturers of devices under MDR | 22 August 2022

State Institute for Drug Control is organising a seminar on manufacturer obligations under MDR on 14th September 2022. The seminar also covers essential topics such as:

  • Road to Regulation of the European Parliament and the Council (EU) 2017/745 (MDR)
  • Validity and transitional periods
  • New requirements resulting from the MDR
  • New requirements resulting from Act 89/2021 Coll.
  • Quality Management System (QMS)
  • Market Surveillance
  • Steps to MDR Implementation       

For more information on the registration, click here.

FAQ Document on device advertising | 08 August 2022

The Department of Medical Devices has issued a new document with the answers to some of the questions from the seminar on medical device advertising. The seminar discussed the various aspects of advertising healthcare devices and in vitro diagnostic devices. The document contains information on topics such as prerequisites for healthcare devices website, places for providing medical devices and IVD samples and others. The document can be accessed here.

GERMANY

Guidance on the authorisation procedure for performance studies and clinical trials | 17 August 2022

The Federal Institute for Drugs and Medical Devices (BfArM) has issued guidance on the authorisation procedure for performance studies and clinical trials of In vitro diagnostics and medical devices. As long as the central European database EUDAMED does not provide the corresponding functionality, the application is submitted via the German Medical Devices Information and Database System (DMIDS, formerly DIMDI) of the Federal Institute for Drugs and Medical Devices (BfArM). 

Per the guidance, a performance study can only be commenced if BfArM has not objected within 10 days of validating the clinical study application. Further information on clinical trials and performance studies can be found here.

Guidance on notification of Other Clinical Investigations | 17 August 2022

The federal institute for Drugs and Medical Devices (BfArM) has issued guidance on other clinical investigations. The guidance is specific to those investigations that are:

  • Not part of a systematic and planned device development or device surveillance process of a current or future manufacturer,
  • Not carried out to demonstrate the conformity of a device with the requirements of Regulation (EU) 2017/745,
  • Serve to answer scientific or other questions; and
  • Conducted outside a clinical development plan referred to in point 1(a) of Part A of Annex XIV to Regulation (EU) 2017/745.

The guidance also shares the procedures to be followed in case of a temporary halt or early termination of a clinical investigation.   

Reporting channels according to MDR and MPDG| 17 August 2022

The Federal Institute for Drugs and Medical Devices (BfArM) has issued guidance on reporting channels until the European Database for Medical Devices is fully operational. Until now, only some essential modules of the EUDAMED are available for registration and notification of medical devices and IVDs. The guidance lists the reporting channels, designated email IDs and the method for Notifications, applications, and reports.

UNITED KINGDOM (UK)

MHRA event on adverse event reporting | 21 August 2022

The following is a summary from a recent MHRA webinar on the new Manufacturer Online Reporting Environment (MORE) used to report vigilance incidents to MHRA.

The new system will go into effect from September and November of 2022, with a final extension for some occurring in April 2023. Between September and November, manufacturers, authorised representatives, and UK responsible persons must upgrade their IT systems and SOPs so that you can register to use the new system (Please note that the exact dates have not been announced).

Manufacturers will be able to create a new MORE account from September, and can be used once MHRA has approved it. The current MORE portal will be decommissioning from November. The present API mailbox will be shut down in April 2023. A test environment will be made available for volunteers interested in utilising the new API.

The new MORE will be a part of the MHRA’s new Safety Connect system and will be linked to other MHRA IT systems and their present Appian device registration system, which handles device registration. The new system will be based on MIR7.2 (the current version of the EU Manufacturer Incident Report form). It is unclear whether or when the MHRA will implement the upcoming MIR7.3 or which version will be used in Northern Ireland, even though the MHRA stated they seek to be compatible with a similar EU system (EUDAMED).

SWITZERLAND

Swiss MedTech event on MDR product certification| 31 August 2022

All MDD/AIMD certificates must be updated by the MDR’s deadline of May 26, 2024. Only 1000 of the 25000 certificates that were cleared by the Notified Bodies (NB) under MDR have been done so yet. The event will be held on 06th September 2022 and will discuss the MDR certification and the documentation requirements to be followed.

Swissmedic Information sheet on clinical investigations of medical devices| 26 August 2022

In the latest information sheet on clinical investigation of medical devices, Swissmedic introduces the application and authorisation procedure of clinical investigation. The review and surveillance of the investigation are also mentioned in the document.

Recommendations on the use of guidance documents released by MDCG | 21 August 2022

The Medical Devices Coordination Group (MDCG) employs guidance documents to assist stakeholders in implementing medical device regulations. MedTech Europe’s position paper explains how these documents should be used without impeding manufacturers’ efforts to comply with the new MDR and IVDR regulations. The paper will now be forwarded to the European Commission, the MDCG, the CAMD, and the notified bodies by MedTech Europe. The entire document can be accessed here.

Updated Swissmedic forms for IVD registration | 08 August 2022

Swissmedic has published an updated form for the product registration of Swiss In vitro diagnostic devices IVD manufacturers under Art. 90 of In Vitro Diagnostics Ordinance (IvDO). Swissmedic has also updated its guidance on performance studies of IVDs.

AUSTRALIA

Post-market review of ventilators, CPAP and BiPAP devices| 23 August 2022

All devices listed in the Australian Register of Therapeutic Goods (ARTG) that fall under the following categories are undergoing post-market reviews by the Therapeutic Goods Administration (TGA) right now:

  • Continuous and non-continuous ventilators
  • Acute care ventilators
  • Ambulatory ventilators, including continuous positive airway pressure (CPAP) devices and
  • Bi-level positive airway pressure (BiPAP) devices

This post-market review identifies risks posed by a polyester-based polyurethane (PE-PUR) foam used as soundproofing material in ventilator, CPAP and BiPAP devices. The review aims to ensure that devices included in ARTG meet essential principles set out in Therapeutic Goods Regulations 2002 and to confirm that the devices are safe for use.         

Australian regulatory guidelines for medical devices (ARGMD)| 19 August 2022

The Australian Regulatory Guidance for Medical Devices (ARGMD) is the regulatory body for medical devices in Australia.

Information required with applications to import, export, manufacture, or supply medical devices in Australia is outlined in the ARGMD. The ARGMD likewise covers the post-market specifications for medical devices. It does not provide regulatory advice on other medicinal devices listed or registered. These products are governed by the Australian Medical Device Requirements Under the Therapeutic Goods Act 1989 (version 4), or DR4, posted on the TGA website.

TGA is currently reviewing and updating the Australian Regulatory Guidelines for Medical Devices (ARGMD). The previous version of ARGMD can be found here. The presentation on the new TGA website can be found in this here.

Guidance document on active medical device requirements | 19 August 2022

The TGA has released a document on active medical device requirements. An active medical device uses and converts significant energy to function. The form of energy used by an active device does not include gravitational or directly provided human energies. The document further discusses different active devices, the application of electromedical safety standards and some specific software requirements.

Consultation on proposed regulatory changes for clinical trials of medical devices| 17 August 2022

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed regulatory changes to improve clinical trial safety oversight for medical devices:

  • To improve regulatory oversight of clinical trials of specific unapproved, high-risk medical devices.
  • Clinical trials of all medical devices should be included in Australia’s Good Clinical Practice Inspection Program (to enable selected trials and documentation supporting these trials to be inspected).

Opening date of consultation: 17 August 2022

Closing date of consultation: 28 September 2022

The consultation document can be accessed here.

Guidance document on the exemption for specific clinical decision support software| 17 August 2022

This guidance offers a thorough understanding of the exemption requirements for specific CDSS and is intended for sponsors, manufacturers, suppliers, and software developers of Exempt Clinical Decision Support Software (CDSS). Exempt software is a medical device but is not required to be included in the Australian Register of Therapeutic Goods (ARTG). The broad CDSS guideline that the TGA released in February 2021 is supplemented by this paper.

The Government revised the Therapeutic Goods (Medical Devices) Regulations 2002 in February 2021 to include new standards for software-based medical devices and clarify certain current ones. Based on the following guidelines, several software-based medical devices were exempted (either through an exception or exclusion) from the TGA regulation:

  • Alignment with international regulatory frameworks where appropriate
  • Reduce or remove unnecessary regulatory burden: by not regulating products where there is no significant risk to safety and where suitable frameworks for product or system oversight are already in place.

Post-market review of antigen and rapid antigen tests| 04 August 2022

The Australian Register of Therapeutic Goods (ARTG) includes all COVID-19-specific laboratory antigen tests and rapid antigen tests (RATs), including point-of-care and self-testing (ARTG). With ongoing work to evaluate their capacity to identify new variations, the review’s goal is to ascertain whether SARS-existing CoV-2’s known variants have influenced tests.

All point of care (PoCT) and self-test RATs included in the ARTG are also subjected to laboratory testing as part of the post-market evaluation to confirm their effectiveness in identifying the Delta and Omicron variants (and other emerging variants of concern).

SARS-CoV-2 virus mutations result in a variation of the virus, which may change the structure of the produced viral protein. Test kits can then lose their ability to identify the virus, producing false-negative findings accurately.

Manufacturers of these tests have given the TGA study data, including recombinant protein studies, live viral studies, inactivated virus studies, and clinical trials, to confirm the effectiveness of their test kits.

Application for priority applicant determination – medical devices| 02 August 2022

A form must be completed and submitted to apply for a priority applicant determination for a medical device(s), along with sufficient supporting information addressing the relevant eligibility criteria.

Please review the Priority applicant guidelines for medical devices before submitting your application (including IVDs). These guidelines describe the application process, the device’s criteria to be considered a priority applicant, and how to pay the application fee. To access the form, click here.

UNITED STATES OF AMERICA (USA)

Medical Device Shortage List Updated By FDA| 26 August 2022

The Food and Drug Administration (FDA) has published a list of device shortages to notify the public, especially those who use or purchase medical devices. The list is required by law to be kept and updated as the COVID-19 public health emergency develops and reflects the categories of devices the FDA has judged to be in low supply. It also satisfies a requirement under section 506J of the FD&C Act. Including a particular device type on this list does not imply that patient care has been adversely affected.

The F.D.A. removed surgical respirators from the device shortage list. In addition, the F.D.A. expanded the list of devices to include two brands of needles and syringes (product code G.A.A.) and two brands of viral transport media (product codes QMC and J.S.M.). The complete list can be accessed here.

FAQ Document On 3D Printing of Medical Devices, Accessories, Components & Parts During Covid-19 Pandemic| 26 August 2022

In response to COVID-19, the F.D.A. continues to take innovative and adaptable strategies to address the issue of access to essential medical items. Because of the increased demand and general disruptions to the worldwide supply chain during the COVID-19 pandemic, the requirement for certain medical items, particularly personal protective equipment (P.P.E.), may exceed the supply available to healthcare organisations. F.D.A. has issued a new document that answers frequently asked questions for organisations that 3D print gadgets, accessories, parts, and components during the COVID-19 emergency. The guidance can be accessed here.

FAQ document on Testing for SARS-CoV-2 | 26 August 2022

The F.D.A. recently released a new document responding to frequently asked questions about Emergency Use Authorizations and Notifications as outlined in the Policy for Coronavirus Disease-2019 Tests.

Federal Register on Medical Device Labelling Regulations | 23 August 2022

The Food and Drug Administration (FDA) seeks public opinion on the available information. This notice requests feedback on the rules governing the labelling of medical devices.

The information gathering process aids in applying section 502 of the FD&C Act’s medical device labelling regulations. Medical device labellers are mandated by the Global Unique Device Identification Database (GUDID) to design and use medical device labels and device packages that bear a Unique Device Identification (UDI), present dates on labels in a specific format, and submit data regarding each version or model of a device no later than the date the label of the device must bear a UDI. Respondents will be expected to update the information submitted if the information changes whenever a device is subject to UDI regulations.

eMDR System Enhancements| 22 August 2022

The FDA’s eSubmitter software is part of an electronic submissions process that is available for voluntary use by sponsors, manufacturers, and importers to create various submission types within the drug, blood, device, radiological health, tobacco, animal drug and animal food regulated industries. Although the FDA eSubmitter client is updated simultaneously with the eMDR system, industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG) should utilise the information on this page to schedule system changes to coincide with these eMDR system advancements as soon as practicable.

The FDA is aware of how critical it is to give manufacturers who send HL7 ICSR XML reports through AS2 early warning and predictability about anticipated eMDR system modifications. As a result, the FDA has decided to announce and implement updates to the eMDR System annually.

Guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products | 16 August 2022

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply specific legal standards for hearing aids and personal sound amplification products (PSAPs), which are included in this guidance. Confusion among stakeholders and customers has been exacerbated by the absence of distinction between PSAPs and hearing aids.

As per the guidance, both hearing aids and PSAPs impact a user’s hearing, but the products are subject to various regulatory controls because of their varied intended uses. Unlike hearing aids, which are meant to help someone with hearing loss or make up for it, PSAPs (defined in Section III) are not meant to identify, mitigate, or treat impairment. They are not meant to alter the structure or functionality of the body, only to treat or prevent disease. Therefore, they are not regarded as “devices” because the term is used in the FD&C Act.

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices| 16 August 2022

The FDA revised its “Replacement Reagent and Instrument Family Policy” for in vitro diagnostic (IVD) devices in 2003 and published it as a guidance. The 2003 guidance outlined a procedure for manufacturers to follow when adapting an assay that had previously been cleared based on performance characteristics when used with a particular instrument to a different instrument that was either cleared or a member of an instrument family from which another instrument had previously been cleared. When evaluated against predefined acceptance criteria using an appropriate validation protocol, manufacturers established sufficient control through the method outlined in the 2003 guidance to maintain the level of safety and effectiveness demonstrated for the cleared device for these types of modified devices without submitting a premarket notification (510(k)).

As FDA continues to advocate for the prompter availability of a wider variety of clinical laboratory tests for patient benefit, FDA feels that this guideline is crucial for public health. This guideline encourages uniform implementation of the ideas in this advice by updating and clarifying the Replacement Reagent and Instrument Family Policy for manufacturers of IVD devices and FDA staff.

Federal Register on Medical Devices: Ear, Nose, and Throat Devices | 16 August 2022   

To modernise the regulatory environment for hearing aids, the FDA is creating a regulatory category for over-the-counter (OTC) hearing aids and implementing associated changes. In particular, FDA defines OTC hearing aids and establishes relevant requirements; modifies current rules to be consistent with the new OTC category; repeals the conditions for sale that apply to hearing aids; modifies the current labelling requirements for hearing aids; and updates regulations relating to decisions on applications for exemption from Federal pre-emption that will become null and void due to changes to the hearing aid requirements. By establishing a regulatory category for over-the-counter (OTC) hearing aids and revising current regulations, the FDA hopes to encourage access to and innovation in the field of hearing aid technology while reasonably assuring these devices’ safety and efficacy.

Federal Register on the Modifications to the List of Recognised Standards, Recognition List Number: 058| 9 August 2022

The set of criteria that the Food and Drug Administration acknowledges for use in premarket evaluations will soon be updated, according to the latest publication of the FDA. Manufacturers that want to declare conformance with consensus standards can benefit from this publication, “Modifications to the List of Recognised Standards, Recognition List Number: 058,” which details the criteria for medical devices.

The FDA is making announcements on the addition, removal, correction, and amendment of a few consensus standards that the Agency acknowledges for use in premarket filings and other device requirements. The FDA Recognised Consensus Standards list in the Agency’s searchable database has been updated to reflect these changes. FDA refers to the current revisions as “Recognition List Number: 058.”

Evaluation of Automatic Class III Designation (De Novo) Summaries| 09 August 2022    

The De Novo classification option was added as an alternative pathway to classify novel medical devices that had previously been automatically placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission by the Food and Drug Administration Modernization Act of 1997 (FDAMA). On July 9, 2012, section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) revised section 513(f)(2) of the FD&C Act to permit a sponsor to submit a De Novo classification request to the FDA without first being required to submit a 510(k) application.

For innovative low- to moderate-risk device categorisation, there are two choices.

  • Anyone who obtains an NSE finding in response to a 510(k) submission may submit a De Novo request for the FDA to conduct a risk-based review for classifying the device into Class I or II within 30 days of receiving the NSE determination.
  • Anyone who decides there are no lawfully marketed devices on which to base a judgement of substantial equivalent may file a De Novo request to the FDA to classify the device into Class I or II based on risk, without first filing a 510(k) and receiving an NSE determination.

Guidance on Colour Additives for Medical Devices| 08 August 2022         

Under certain circumstances, the same rules that govern colour additives in foods, medicines, and cosmetics also apply to colour additives in medical devices. According to Section 721(a) of the Food, Drug, and Cosmetic Act (the Act), devices containing a colour additive is deemed adulterated unless a regulation specifies the colour additive’s intended use. The colour listing regulation may allow the colour additive to be used in a general-purpose device, like contact lenses, or it may impose restrictions on its use, like using polypropylene nonabsorbable sutures only for general surgical procedures and not for ophthalmic procedures. The definition of colour additive and the specific links to the regulation can be accessed here.

Updated Guidance on Breast Implants| 08 August 2022 

The FDA has taken several new actions to improve breast implant risk communication and assist those considering breast implants in making informed decisions.

First, the FDA issued orders limiting the sale and distribution of breast implants to help ensure that patients thinking about getting breast implants are given enough risk information to make fully informed decisions.

Second, the FDA approved new labelling that says the following for all legally marketed breast implants:

  • Boxed warning
  • To make sure the patient is aware of the risks, advantages, and other details associated with the breast implant device, the healthcare provider must go over the patient decision checklist with the potential patient. The patient decision checklist must be initialled by the patient and signed by both the doctor implanting the device and the patient
  • Updated recommendations for screening for breast implant ruptures filled with silicone gel
  • A detailed description of the device along with a list of its specific components
  • Patient Device card

Further reading on the topic can be accessed here.

Updated guidance on Breakthrough devices program| 03 August 2022

The Breakthrough Devices Program is a voluntary programme for specific medical devices and device-led combination products that offer more efficient treatment or diagnosis of fatal or permanently crippling diseases or conditions.

The purpose of the Breakthrough Devices Program is to expedite the development, evaluation, and review of these medical devices while maintaining the legal requirements for premarket approval, 510(k) clearance, and De Novo marketing authorisation, in line with the Agency’s mission to safeguard and advance public health. The updated guidance now contains breakthrough device program metrics.

Updated guidance on Sterilisation of medical devices| 03 August 2022        

Various sterilisation techniques are used to clean medical equipment, including steam, dry heat, radiation, ethylene oxide gas, vaporised hydrogen peroxide, and other sterilisation techniques (for example, chlorine dioxide gas, vaporised peracetic acid, and nitrogen dioxide). FDA has released a statement on its efforts to support innovation in medical device sterilisation.

SAUDI ARABIA

SFDA publishes updated forms for medical devices| 08 August 2022 

Saudi Food and Drug Authority (SFDA) has issued updated forms for medical device manufacturers.

A list of updated forms includes:

  • Corrective action implementation plan
  • Field safety closure report
  • Risk assessment
  • Clinical investigation
  • Device malfunction report
  • Device accident report.

JAPAN

Webinar on Implementation of IMDRF documents in the Japanese Regulations| 22 August 2022

The Pharmaceuticals and Medical Devices Agency (PMDA) is organising the “PMDA-ATC Medical Devices Webinar 2022 – Implementation and Adaptation of Japanese Medical Device Regulation based on GHTF/IMDRF documents”. The Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) will offer the webinar. Key objectives of the webinar include:

  • Regulations of specific medical devices, especially in IVD medical devices, AI-based medical devices, High risk (Classes C and D) medical devices and software as a Medical Device (SaMD)
  • Up-to-date information about some specific medical devices.

SINGAPORE

HSA update on Paclitaxel-Coated Devices for Peripheral Arterial Disease | 22 August 2022

Peripheral arterial disease (PAD) typically arises when blood flow to the limbs is restricted due to plaque buildup in the arteries. In patients with PAD, paclitaxel-coated balloons (PCB) and paclitaxel-eluting stents (PES) are used to open the stenotic or blocked vessel. These devices release paclitaxel to lessen the likelihood of re-stenosis in the treated artery.

A comprehensive analysis of randomised controlled trials (RCT) published in 2018 revealed an increased risk of death at 2 to 5 years following the use of PCB and PES devices to treat PAD.

Considering this research, HSA released anannouncement advising medical professionals to:

  • Continue monitoring patients who have received paclitaxel-coated devices for PAD using the most recent standards of medical care
  • When considering using such devices, weigh each patient’s clinical benefits and risks.

INDIA

List of notified bodies under MDR |25 August 2022

Central Drugs Standard Control Organisation (CDSCO)has issued a list of Notified bodies under MDR. The document has an updated list of notified bodies registered with CDSCO that can carry out the audit of a manufacturing site. The complete list can be accessed here.

List of certified medical device testing labs under MDR |17 August 2022     

Central Drugs Standard Control Organisation (CDSCO)has issued a list of Medical Device testing laboratories to carry out tests on behalf of the manufacturer. There are about 18 device test labs till 07th December 2021. The document has an updated list of laboratories, the registration number, and the scope of tests available in the specific lab. The complete list of Medical Device testing laboratories can be accessed here.

Classification of medical devices pertaining to Rehabilitation under Medical Device Rule 2017| 04 August 2022    

Central Drugs Standard Control Organisation (CDSCO) has updated its list of medical devices for rehabilitation. The requirements of the Drugs and Cosmetics Act of 1940 govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules (MDR) for regulating medical devices in import, production, clinical evaluation, sale, and distribution, following consultation with the Drugs Technical Advisory Board. The updated list of medical devices under MDR includes acupressure calf band and Arthritis TENS system, among other medical devices that aid rehabilitation. The complete list of medical devices and the product class can be accessed here.

Draft guidance on In vitro Diagnostic Medical devices | 07 July 2022

CDSCO has released draft guidance on the overview of performance evaluation, stability studies and post-market surveillance of In vitro Diagnostic Medical Devices. The draft guidance is out for public comment. The complete document can be accessed here.

COSMETICS

FAQ document on registration for import and manufacture of cosmetics – India|17 August 2022

The Cosmetics Rules, 2020, have been published with effect from 15.12.2020. On commencement of these new cosmetic rules, the office has received various concerns and challenges faced by the stakeholders regarding application for grant of import registration certificates and subsequent endorsements. Therefore, to streamline the process of import registration of cosmetics and address these issues, it has been decided to provide detailed clarification on these issues. Accordingly, an additional set of FAQs (annexed) have been prepared considering the Cosmetics Rules 2020 for information of all the stakeholders. The full document can be accessed here.

Restriction of Use of Methyl N-Methyl anthranilate (MNM) in Cosmetic Products- Saudi Arabia|22 August 2022  

Saudi Food and Drug Authority has issued circular 24366 on the restriction of the use, including regulating the use of (Methyl N-Methyl anthranilate (MNM) in cosmetic products. The circular comes ineffective from the 07th of January 2022. After evaluating the latest evidence and studies, the authority decided that it is allowed to add Methyl N-Methyl anthranilate (MNM) in rinseable cosmetic products. Rinse-off products can contain quantities not exceeding 0.2%. Circular also puts in place the following restrictions:

  • Do not use nitrosating agents cosmetics:
  • Maximum nitrosamine content: 50 µg/kg
  • Keep in nitrite-free containers

SFDA guide to reporting, recalls, and manufacturing errors for cosmetic products | 22 August 2022 

The latest guide released by the Saudi Food and Drug Authority (SFDA) introduces the requirements for cosmetic products. The guide includes the details from side effects caused by certain cosmetic ingredients to reporting side effects and the timelines for reporting to be followed by manufacturers. The below table describes the reporting timeframes to be followed once users report side effects.

Type of errorMaximum Reporting Timeframe
Product recall10 Days
Serious side effects or manufacturing fault20 days

ISO STANDARDS

Published ISO Standards for August 2022

List of Published ISO standards for medical devices and in-vitro diagnostic devices

  • BS EN ISO 11608-1:2022 Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems
  • BS EN ISO 11608-2:2022 Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles
  • BS EN ISO 11608-3:2022 Needle-based injection systems for medical use. Requirements and test methods. Containers and integrated fluid paths
  • BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices
  • PD ISO/TR 12417-2:2022 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. Local regulatory information
  • BS EN ISO 10942:2022 Ophthalmic instruments. Direct ophthalmoscopes
  • BS EN ISO 8980-3:2022 Ophthalmic optics. Uncut finished spectacle lenses. Transmittance specifications and test methods
  • BS EN ISO 10079-3:2022 Medical suction equipment. Suction equipment powered from a vacuum or positive pressure gas source
  • ISO/TS 5798:2022 In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) by nucleic acid amplification method

List of Published ISO standards for cosmetics

  • ISO 24442:2022 Cosmetics — Sun protection test methods — In vivo determination of sunscreen UVA protection

July Newsletter 2022

EUROPEAN UNION (EU)

Harmonised administrative practices and alternative technical solutions| 13 July 2022

The MDCG guidance document advises the Member States and other relevant parties on applying specific IVDR regulations in the absence of Eudamed. This guidance defines harmonised administrative processes and alternative technology alternatives for information interchange until Eudamed is entirely operational. Based on the appropriate provisions of Directive 98/79/EC, this guidance covers specific instances when information exchange would be difficult, if impossible, to execute.

Implementation of Regulation (EU) 2022/1107 for common specifications under Regulation (EU) 2017/746| 5 July 2022

The European Commission has established common standards for high-risk diagnostics, including HIV tests and SARS-CoV-2 assays. The guidelines establish uniform and stringent criteria for tests across the EU, clarifying the requirements for market participants and protecting EU patients. Annexes I to XIII of EU Regulation 2022/1107 specify the various standards to be met by Class D in vitro diagnostic medical devices in terms of performance characteristics. Annex XIII defines the standards for devices that detect or quantify markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The EU Regulation 2022/1107 can be accessed here.

ITALY

Webinar on “CLV of cosmetic products – procedures and critical issues”| 11 July 2022

An online event titled “CLV of cosmetic products – procedures and critical issues” is organised by the Directorate General for Medical Devices and Pharmaceutical Service – DGDMF (Office 8) and is targeted at businesses in the industry interested in applying for Certificates of Free Sale (CLV) for “export of cosmetic products.” To know more on the topic, click here.

UNITED KINGDOM (UK)

Updated Guidance on Registering Medical devices in UK| 28 July 2022

Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on medical device registration in the UK. The guidance now contains a specific Coronavirus Test Device Approval (CTDA) section. Persons planning to supply, put into service, or place a coronavirus test device on the UK market must apply for clearance from the UK’s Health Security Agency (UKHSA).

The MHRA will not accept registration applications for covid test devices until they have received Coronavirus Test Device Approval (CTDA) or are placed on the Temporary Protocol list.

Over 285,000 medical devices and medicines seized in UK | 20 July 2022

In the latest press release by the Medicines and Healthcare products Regulatory Agency (MHRA), over 285,000 illegal drugs and medical devices were seized. The MHRA have seized large quantities of illegally traded medicines and medical devices in an Interpol week of action known as “Operation Pangea”.

Over £850,000 in medicines and medical devices, totalling over 285,000 items, have been seized by officers from the UK’s MHRA as part of a global operation to combat the illegal sale of medical products, with UK seizures estimated to be worth around 9% of the global total.

Guidance on Innovation Accelerator | 26 July 2022

Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the Innovation accelerator, which aims to provide access to MHRA’s scientific expertise, regulatory assistance, and enhanced advice and signposting service for inventors and developers of novel products. It provides regulatory information, advice, and guidance to organisations of all sizes and backgrounds based in the UK or globally (industry, academics and patient groups).

The Innovation Office is open to queries from those developing innovative medicines, medical devices, manufacturing processes and blood components for transfusion.

Public consultation on future regulation of medical devices | 26 June 2022

MHRA has released a document on the future regulation of medical devices in the UK by MHRA. The document contains feedback from a wide demographic, including healthcare professionals and manufacturers. The highlights of this document include:

  • Possible reclassification of medical devices increased post-market surveillance of medical devices
  • Implementation of improved traceability of medical devices
  • Government to introduce Alternative market routes
  • Rescheduled CE marked devices acceptance and UKCA dates.

SWITZERLAND

New EUDAMED information Center launched | 21 July 2022

The European Commission has launched the new EUDAMED Information Center. It combines all EUDAMED Production User Guides, offers rapid and organised access to all relevant information, and includes a contact form for users to contact the EUDAMED Support Team. For more information, click here.

MedTech Europe Survey Report on MDR implementation| 20 July 2022

MedTech Europe performed a study with 475 responses from major and small businesses to quantify medical device availability. According to the findings, less than 15% of medical equipment has previously gained MDR certification. The time to certification has increased to 13-18 months, and more than 15% of SMEs still do not have access to an MDR-designated Notified Body. As a result, over half of respondents believe they will deprioritise the EU market for new device regulatory approval. The report discusses how MDR implementation will affect the EU medical device market.

Swissmedic information sheet on in-vitro diagnostic device notifications | 14 July 2022

Swissmedic has released an updated document on in vitro diagnostic medical devices. The information sheet answers some of the frequently asked questions on IVD notification. The document contains information on when the notification form for IVDs must be submitted, the timeline for processing the application and other important information.

AUSTRALIA

Unique Device Identification system: Communications and stakeholder engagement| 18 July 2022

The success of the UDI system needs to involve health professionals, healthcare organisations, consumers, and industry in its creation and implementation. The TGA will interact and consult with stakeholders to ensure that all viewpoints, notably those of medical device users, are considered. The TGA’s public reporting will guarantee that the TGA’s progress toward establishing the UDI system is transparent. Click here to access the latest webinar on UDI implementation.

Safety information on home use fetal dopplers (heartbeat monitor) | 07 July 2022

The TGA is now studying foetal cardiac monitors’ safety indicators, advantages, and disadvantages for home use. This review is shared with consumers and healthcare professionals. The TGA’s examinations will help assess whether utilising these gadgets carries more risk than the potential benefit.

Fetal dopplers are handheld devices that track the foetal heart rate between 10 and 12 weeks of pregnancy. Traditionally, health workers have employed these tools in clinical settings. Fetal dopplers for home usage have become readily accessible recently, and users don’t need special training to use them. The TGA is aware of instances in which Fetal dopplers for home use have led to patients receiving delayed medical care and false reassurance. The Royal Australian and New Zealand College of Obstetricians and Gynecologists and the US Food and Drug Administration (US FDA) have released guidelines on using these monitors. Both do not encourage the usage of home doppler equipment to detect the foetal heartbeat.

UNITED STATES OF AMERICA (USA)

Patient Labelling Recommendations for Laser-Assisted In Situ Keratomileusis (LASIK) Lasers | 27 July 2022

The content and formatting for patient labelling information for laser-assisted in situ keratomileusis (LASIK) devices are recommended in this guidance document. This guidance is to help ensure that both physicians and patients understand the benefits and dangers of these devices. The recommendations are issued in response to concerns that some patients are not receiving or understanding information about the benefits and hazards of LASIK equipment. The labelling suggestions mentioned in the document are meant to supplement, not replace, physician-patient discussions about the advantages and dangers of LASIK devices that are unique to patients.

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices | 22 July 2022

In this guidance, the FDA modified the Global Unique Device Identification Database (GUDID) submission requirements for several class I devices considered consumer health goods. In particular, the FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices requiring a UDI on their labels and device packages because they are deemed consumer health items. Furthermore, the FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices, before December 8, 2022, regardless of whether they are consumer health products (an additional 75 calendar days).

Medical Device Types for Section 506J Notification Obligation | 19 July 2022

FDA has updated the guidance containing suggestions based on the device types and corresponding product codes for manufacturers when they are required to notify FDA during the COVID-19 pandemic under section 506J. Section 506J of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of specific devices that leads to a disruption in the supply of that device in the United States.

FDA has listed the device types and their corresponding product codes so that manufacturers can consider whether they are required to notify FDA during the COVID-19 pandemic under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Tracking Premarket Submission’s Progress (Progress Tracker) | 18 July 2022

The Center for Devices and Radiological Health’s (CDRH) progress in assessing Traditional, Abbreviated, and Special 510(k) applications is tracked by the FDA using a secure, web-based tracker. Official Correspondent can now track the FDA’s progress online when you submit a 510(k) submission to CDRH for review in a clear, concise manner.

The FDA provides online progress tracking to uphold its obligations under the Medical Device User Fee Act (MDUFA). The application tracker can be accessed here.

510(k) Third Party Review Organization Performance Report for FY22 – Q3| 8 July 2022

The FDA Modernization Act of 1997 (FDAMA) established the Accredited Persons Program to enhance the effectiveness and timeliness of the FDA’s 510(k) procedure. As part of the programme, the FDA accredits Third Parties (Accredited Persons) qualified to perform the initial 510(k) reviews for admissible devices.

In accordance with MDUFA (Medical Device User Fee Act) IV, the FDA committed to publicly making online the performance of each accredited Third Party with at least five successfully submitted documents (e.g., the specific number of holds and the typical turnaround time for decisions). Every quarter, a summary of Third-Party Performance Metrics will be published. Data from FY 2018, Q1 through FY 2022, and Q3 are included in this study (October 1, 2017, through June 30, 2022). The report can be accessed here.

COSTA RICA

Health reform decree to simplify the registration of low-risk processed foods and cosmetics| 06 July 2022

The sanitary registration of processed foods and low-risk cosmetics will be made easier by an amendment to executive decree 43291-S. The operation, which formerly took 30 days to complete, must be finished immediately. According to Minister of Health Joselyn Chacón Madrigal, the purpose of this kind of reform is to make the nation more competitive to draw investment and facilitate business through digital governance. The list of cosmetic items has also been expanded to include items for the face (moisturising creams, masks, and powders), mouthwash, and alcohol solution for hand cleansing.

BAHRAIN

Bahrain Health Regulatory Conference on 27-29 September 2022| 26 June 2022

The National Health Regulatory Authority (NHRA) will hold Bahrain’s 2nd Health Regulatory Conference. Government healthcare decision makers, health reform and regulation experts, pharmaceutical and drug company owners, public and private healthcare providers, investors and interested experts in the healthcare business, technology experts, solution providers, and healthcare professionals will all be present at the exhibition. The exhibition will take place from 27th -29th September 2022.

This is an opportunity to exchange knowledge and thoughts while participating in an educational platform.

CHINA

China approves new domestically developed ‘artificial heart’| 17 July 2022

“Artificial heart” for severe heart failure developed in China has received commercial permission from the NMPA of China.

The TEDA International Cardiovascular Hospital and the China Academy of Launch Vehicle Technology collaborated to develop the artificial heart; they have been researching the third generation of ventricular assist devices in China since 2009.

According to the Annual Report on Cardiovascular Health and Diseases in China (2021), published in late June, there are 8.9 million heart failure patients in China. According to the report, 58 of the 68 medical devices that the NMPA authorised to join its “innovative medical device evaluation channel” between September 2020 and August 2021 were Chinese.

MALAYSIA

Full enforcement of medical devices regulations 2019 from July 2022| 01 July 2022

Malaysia’s Medical Device Authority (MDA) has announced that the Medical Devices Regulations 2019 will be implemented entirely from July 1, 2022.

With full enforcement of this Regulation, all parties involved in the importation, distribution, and placement of medical devices on the market are required to comply with all of the requirements set out in this Regulation, which generally set out post-market control requirements, such as complaint handling, mandatory problem reporting, corrective and preventive actions in the field (field corrective action) and recall for medical devices. Further information regarding labelling can be found here.

SINGAPORE

Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs | 01 July 2022

An updated version of the Regulatory Guidelines for Laboratory Developed Tests (LDTs) has been made available by the Medical Devices Cluster (MDC) for stakeholder consultation. Under the Healthcare Services Act, clinical laboratories are currently subject to MOH regulation and licencing (HCSA). Considering the present regulatory requirements that apply to clinical laboratories under HCSA, the regulatory approach for LDTs will be based on the current regulatory standards applicable to commercial in-vitro diagnostic devices (IVDs).

The document provides an overview of the scope of LDTs and the regulatory requirements applicable, including Product controls, Manufacturing Quality controls and Post-market controls.

JAPAN

Health Science Council Pharmaceuticals and Medical Devices System Subcommittee to be held on 05 August 2022| 22 July 2022

A Subcommittee will be held on the 5th  of August 2022. The agenda includes:

  • Discussions on the revised Pharmaceuticals and Medical Devices Act
  • Working group on the work of pharmacists and the functions of pharmacies
  • Others relevant topics

Study Group on Early Introduction of Medical Devices with High Medical Needs will be Held | 20 July 2022

This study group aims to identify in-vitro diagnostic medications and medical devices with significant unmet medical requirements that are not licenced or indicated in Japan and to consider their fast introduction into clinical practice.

INDIA

Notice regarding non-notified medical devices | 11 July 2022

According to notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices in the Class A and Class B categories are expected to enter the licencing regime by October 1, 2022. For Class A and Class B medical devices, a transition period of 30 months from the date of introduction of G.S.R. 102(E), i.e., 01.04.2020, has been provided for the transfer to the licencing regime.

In the notice, CDSCO strongly recommends that all manufacturers apply for a manufacturing licence for Class A and Class B medical devices using CDSCO’s online portal so that the manufacturing licence can be obtained from the various State Licensing Authorities following a review of the applications and audit.

Classification of medical devices pertaining to Rehabilitation under Medical Device Rule 2017| 06 July 2022

The requirements of the Drugs and Cosmetics Act of 1940 govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules (MDR) for regulating medical devices in import, production, clinical evaluation, sale, and distribution, following consultation with the Drugs Technical Advisory Board. The updated list of medical devices under MDR includes acupressure calf band and Arthritis TENS system, among other medical devices that aid rehabilitation. The complete list of medical devices and the product class can be accessed here.


Please note: Always refer to the regulations in the respective ministry of health website for authorised news and releases.

June Newsletter

 

EUROPEAN UNION (EU)

Guidance document on the implementation of EU product rules 2022 | 29 June 2022

The ‘Blue Guide’ on EU product rules 2022 (Document Number (2022/C 247/01). This guidance discusses both non-food and non-agricultural products, referred to as products for use by consumers or professionals. It applies to medical and in-vitro diagnostic devices that comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746. It covers various topics such as the actors in the supply chain, product requirements and market surveillance of products in the EU market.

Notice to manufacturers to ensure timely compliance with MDR requirement| 13 June 2022

The regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has altered dramatically after the introduction of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). Five years have passed since their adoption. The document is a notice to manufacturers to ensure the timely compliance of medical devices with the deadlines.

The document further explains that the MDR will fully apply to all medical devices on May 27, 2024. Therefore, manufacturers are responsible for ensuring that their devices comply with the MDR once the transition period ends. Medical devices that have not been certified under the MDR will no longer be able to enter the EU market after that date.

CZECH REPUBLIC

CAMD Statement on the transition to MDR and the capacity of the medical device system | 20 June 2022

Following the debate on the transition to MDR and the capacity of the medical device system during the French Presidency of the EU Council, the CAMD (Committee of Competent Authorities for Medical Devices) adopted a statement at its 50th plenary session. The statement can be found here.

1. CAMD is aware of the significant and pressing issues in establishing enough capacity and preparedness for all stakeholders with proper regulatory infrastructure by May 2024. So far, the research reveals that there are various causes and no single remedy. Finding solutions is a collaborative effort.

2. CAMD recognises that if these issues are not resolved promptly, they may cause disruptions in the supply of products to health systems and patients and impede the introduction of novel medical devices into the European market.

3. When addressing urgent capacity concerns, the CAMD believes it is equally critical to explore and resolve root causes.

Relocation of seminar on Obligations of custom-made ZP manufacturers under Regulation (EU) 2017/745 of the European Parliament and of the Council| 07 June 2022

Due to a low number of participants, the seminar “Obligations of makers of custom-made ZP according to Regulation (EU) 2017/745 of the European Parliament and of the Council” scheduled for 16.6.2022 has been postponed to September 2022. The new seminar date will be announced well in advance, and those who have already registered will be contacted personally.

Performance studies on Register of Medical Devices | 30 May 2022

With regard to the postponed launch date of the EUDAMED database, the IVDR includes transitional provisions that allow the use of the Register of Medical Devices (hereinafter referred to as “RZPRO”) for agendas that will be carried out in the future through the EUDAMED database.

These transitional provisions for IVDR provide that, until the performance study module is fully operational, the RZPRO shall be used for the application, notification and registration of SFZs, the notification of substantial changes and the reporting of serious adverse events arising during the SFZ. The new SFZ reporting module has already been launched in RZPRO and can already be used for these purposes. Notification of SFZ will be carried out from the effective date of the IVDR according to the requirements of this legal regulation. This also impacts the reporting of performance studies (from now on referred to as “SFZ”).

FINLAND

Presentations on clinical investigations of medical devices have been published on Fimea’s website | 1 June 2022

On May 17, 2022, Fimea hosted a research webinar to address the changes brought about by new EU laws to the application and notification processes, application materials, and clinical assessment of medical devices and in vitro diagnostic medical devices. Other subjects covered were national legislative requirements and Fimea regulations for clinical investigations and performance studies conducted in Finland.

The webinar presentations, as well as the questions and answers posted on the chat forum during the webinar, are now available on Fimea’s website and can be accessed here.

IRELAND

CAMD publish plenary meeting statement and certificates of free sale Q&A document| 22 June 2022

The Competent Authorities for Medical Devices (CAMD) issued a statement regarding the transition to the Medical Devices Regulation (MDR) and the capabilities of the medical device system.

In this statement, the CAMD:

(1) Recognizes the urgent challenges relating to sector capacity and readiness ahead of May 2024 (notified body certificates issued in accordance with previous directives will become void from this date), which, if left unaddressed, may affect the supply of critical and innovative devices to the EU market.

(2) Outlines their commitment to collaborate with EU colleagues and key stakeholders to find solutions to these difficulties and avert supply interruptions.

(3) Agrees that solutions should focus on getting producers on the right track to compliance rather than reinterpreting MDR requirements or derogations given by national competent authorities.

(4) Requests that work on finding answers to these problems be expedited.

HPRA Guide on the Performance Studies Conducted in Ireland| 16 June 2022

This HPRA Guidance is intended to assist sponsors and other stakeholders in preparing to implement the IVDR’s Performance Study (PS) requirements. Performance studies are regarded to be carried out in the Republic of Ireland if the study:

  • site is based in the Republic of Ireland,
  • participants/specimens originate from the Republic of Ireland.

In general, several PS in Ireland require an application or notification to the HPRA under the IVDR. Section 3 has further information. It is worth noting that some PS require two forms of review, one from a National Competent Authority for in vitro diagnostic medical devices and another from a relevant Research Ethics Committee. In Ireland an ethics opinion can be sought from the National Office for Research Ethics Committees; further information can be found on the NREC website (www.nrecoffice.ie)

HPRA notification on Substantial Modification of a Clinical Investigation of a Medical Device| 08 June 2022

If the sponsor wishes to make changes to a clinical investigation in Ireland that are likely to have a significant impact on the subjects’ safety, health, or rights, or on the robustness or reliability of the clinical data generated by the investigation, they must notify the HPRA at least 38 days before implementation with notification form for substantial modification of a clinical investigation.

ITALY

Establishment of the mandatory national register for breast prosthetic implants | 03 June 2022

In the session on May 26, 2022, the State-Regions Conference expressed support for the draught decree establishing the National Register of Breast Prosthetic Implants. Regional and provincial registries will feed the national breast implant registry. The registry will contribute to the independent assessment of the safety and long-term performance and traceability of breast implants throughout the national territory.

Regional and provincial registries will feed the national breast implant registry. The register will aid in the impartial assessment of the safety, long-term performance, and traceability of breast implants across the country. The record will allow the regions and autonomous provinces to conduct clinical monitoring of the patient receiving implantation and recall him if necessary or subject him to specific follow-ups.

UNITED KINGDOM (UK)

UK to strengthen regulation of medical devices to protect patients| 26 June 2022

The MHRA has issued a press release outlining intentions to strengthen medical device regulation to increase patient safety and foster innovation. The MHRA intends to modernise medical device regulation to improve patient health and foster innovation.

The UK is seizing the opportunities provided by leaving the EU to bring forward new legislation that goes further to improve people’s health. The UKCA label will be used to indicate that products have met these world-class requirements.

MHRA joins international partnerships to set global standards for medicines and medical devices regulation| 16 June 2022

The MHRA announced its acceptance as a full member of three international work-sharing partnerships. In the press release issued by MHRA, intentions to strengthen medical device regulation to increase patient safety and foster innovation is outlined. Through these collaborations, the MHRA will share experience with other prominent organisations, assist in the development of regulatory guidelines, and promote better regulatory harmonisation around the world.

UNITED STATES OF AMERICA (USA)

Establishment Registration and Device Listing for Manufacturers and Importers of Devices | 23 June 2022

The Office of Management and Budget (OMB) has received a proposed collection of information from the Food and Drug Administration (FDA) for evaluation and clearance in accordance with the 1995 Paperwork Reduction Act. Medical device establishment owners and operators must electronically submit establishment registration and device listing information in accordance with section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and its implementing regulations in 21 CFR part 807, subparts A through D.

To achieve several statutory and regulatory objectives, such as:

  • identifying establishments manufacturing marketed medical devices.
  • identifying establishments manufacturing a specific device when that device is in short supply or is required for a national emergency.
  • facilitating recalls for devices marketed by owners and operators of device establishments; and
  • identifying an establishment that produces a specific device, complete and accurate registration and listing information is required.
  • managing post-marketing surveillance programmes for devices.
  • identifying those that have been illegally promoted.
  • identifying and controlling those that have been imported from outside; and
  • arranging inspections of registered businesses in accordance with section 704 of the FD&C Act.

Guidance on Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures | 21 June 2022

The FDA’s suggestions for non-clinical performance testing to support premarket submissions for gynaecologic and general laparoscopic power morcellation containment systems are included in this draft guidance document. These are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so that the tissue can be removed through a small incision site. It may also assist manufacturers in adhering to the special controls for non-clinical performance data for these devices. This advice offers suggestions on:

  • test procedures,
  • test parameters, and
  • test acceptance standards and is applicable to tissue containment systems utilised during a power morcellation operation for both gynaecologic and general application.

The recommendations are meant to encourage uniformity and allow effective consideration of applications for general and gynaecologic laparoscopic power morcellation containment systems. The suggestions are being made to make sure that non-clinical test methods can efficiently uncover safety risks connected to damage to the tissue containment system and subsequent leakage of any cancer cells and other contents.

Additionally, the FDA is advising manufacturers to provide more precise information on the risks of usage as they pertain to age, the danger of spreading both benign and malignant uterine tissue, and the use of LPM containment systems in the labelling for these devices. The product labelling guidance are meant to supplement, not to replace, the doctor-patient conversation about the advantages and disadvantages of using LPMs that are particular to each patient.

Information about Consensus Standards | 07 June 2022

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21, Code of Federal Regulations (21 CFR), Parts 1-58, 800-1299, both contain regulatory rules that apply to medical devices marketed in the US. The risk associated with the device determines the regulatory controls required to ensure a reasonable assurance of safety and efficacy, as well as the marketing channels. Premarket Notification (510(k), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol, Humanitarian Use Exemption, and Biologics License Application are some of the marketing channels (BLA).

A device can be commercialised in four steps:

  • Classify your device and comprehend the relevant regulatory controls.
  • Select and complete the appropriate premarket submission
  • Send your Premarket Submission to the FDA and Communicate with FDA Staff During Review
  • Comply with Applicable Regulatory Controls, Including the Establishment Registration and Device Listing.

BRAZIL

Update of instructions for use of medical devices: understand| 06 June 2022

Updates to instructions for use resulting from needed approval changes should be posted to the medical device document repository only when the appropriate change requests have been approved and published.

Regularization processes for products that obtain updated instructions for use with information originating from requests for modification of approval necessary prior to their approval and publishing indicate an irregularity in the product registration process. As stated in Article 6 of The Collegiate Board Resolution (RDC) 431/2020, “companies that submit information that does not conform with current legislation and consistency with the regularised product are liable to the penalties set for in Law No. 6,437/1977.”

Anvisa technical note on ozone therapy technology in medical devices| 06 June 2022

Anvisa has received multiple requests for the regularisation of medical devices emitting ozone for a variety of purposes. In this regard, the Agency has recently issued a technical comment on ozone therapy technology used in medical devices.

The document includes the Agency’s current list of indications for medical equipment. This includes:

  • Dentistry: antimicrobial action in the treatment of dental caries
  • Periodontics: prevention and treatment of inflammatory/infectious conditions
  • Endodontics: potentiation of the sanification phase of the root canal system
  • Dental surgery: aid in the process of tissue repair;
  • Aesthetics: aid in skin cleansing and asepsis;

Anvisa webinar addresses software regularization as a medical device| 01 June 2022

On June 13th, 2022, Anvisa hosted a virtual seminar to highlight the key topics of The Collegiate Board Resolution (RDC) 657/2022, which provides for the regularisation of software as a medical device (Software as a Medical Device – SaMD). Participants will be able to clear up any misconceptions about the subject of software regularisation.

New standard on CBPF medical devices comes into force| 01 June 2022

Anvisa informs that the Resolution of the Collegiate Board (RDC) 687/2022, which specifies the conditions for granting or renewing the Certification of Good Manufacturing Practices (CBPF) of medical devices, goes into effect on 01st June 2022. RDC 183/2017 is superseded by this standard. Furthermore, the new resolution intends to clarify the issues frequently presented by the former norm, such as those regarding plant plants susceptible to certification. Another innovation is the publishing of Anvisa’s risk matrix utilised in the certification process, which attempts to increase transparency and predictability in the productive sector.

AUSTRALIA

Post-market review of antigen and rapid antigen tests| 22 June 2022

The TGA is reviewing all COVID-19 specific laboratory antigen tests and rapid antigen tests (RATs), including point-of-care and self-tests, included in the Australian Register of Therapeutic Goods (ARTG). With ongoing work to evaluate their capacity to identify newly developing variants, the review’s goal is to ascertain whether tests have been impacted by the known variations of SARS-CoV-2 at this time.

All point of care (PoCT) and self-test RATs included in the ARTG are also subjected to laboratory testing as part of the post-market evaluation to confirm their effectiveness in identifying the Delta and Omicron variants (and other emerging variants of concern).

SARS-CoV-2 virus mutations result in a variant of the virus, which may change the structure of the produced viral protein. Test kits can then lose their ability to accurately identify the virus, producing false-negative results.

Manufacturers of these tests have given the TGA study data, including recombinant protein studies, live virus studies, inactivated virus studies, and clinical studies, to validate the effectiveness of their test kits.

TANZANIA

Notice to traders of treatment equipment on use of customer accounts when applying permits through the system – online portal| 06 June 2022

TMDA notified the medical devices purchasers about the checking of their accounts for medical devices and reagents they have registered in the TMDA accreditation application system, which is accessible at mis2.tmda.go.tz/portal.

It was discovered throughout the review that some consumers had been using several accounts on the system. Due to the customer’s inability to see their registered products on the system, they choose to send the request in a customised order, which slows down the application processing and ultimately delays the issue of permits.

Customers who have several accounts must advise TMDA of which accounts should be used and which ones should be closed before June 30, 2022. To send the information, use the email address [email protected].

In order to guarantee their quality, safety, and efficacy, the Authority also wants to implore all of its clients who purchase medical supplies and reagents to register their goods before they are imported.

SAUDI ARABIA

Updates on the compliance timeframe for Unique device identification in Saudi Arabia| 06 June 2022

The latest guidance from SFDA on unique device identification requirements (Saudi-DI) for medical devices mentions the timeframe for the implementation of UDI on the various device classes. Saudi has released the SFDA UDI database for all medical devices. The below table shows the compliance dates that must be followed.

Compliance timeframe
Launching the UDI database and starting optional registration01 October 2020
Risk ClassCompliance date
Class D 01 September 2023
Class B and Class C01 September 2023
Class A01 September 2024

BAHRAIN

Mandatory of using QR code for reporting Medical Devices complaints| 29 June 2022

In this circular, the National Health Regulatory Authority ( NHRA ) emphasises the importance of using the QR code and placing it in a prominent location for simple reporting of medical device complaints in order to ensure the quality of medical devices and the safety of patients and users. This is to ensure the safety of their use and maintenance in order to ensure patient safety.

INDIA

Classification of Dental, Obstetrical and Gynaecological Under the provision of Medical Devices Rules 2017| 06 June 2022

Safety, quality, and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940. The list of dental products now regulated under the Medical device rules 2017 is given in this document and the Obstetrical and Gynecological products can be accessed here.

May Newsletter 2022

May Newsletter 2022

EUROPEAN UNION (EU)

Stricter rules for placing medical tests on the market | 25 May 2022

From 26 May 2022, new laws for in vitro diagnostic medical devices (IVDR) such as HIV testing, pregnancy tests, and COVID-19 tests are in effect. The guidelines will improve public health and patient safety for these devices, putting EU law in line with technological advancements and medical research progress. It also ensures equitable market access for manufacturers by unifying market access standards across the EU Member States. 

In summary, the In Vitro Diagnostic Medical Devices Regulation introduces three significant advancements: 

  • In vitro diagnostic medical equipment’s quality, safety, and reliability are improved. 
  • Transparency and information for patients are improved. 
  • Improves market surveillance and vigilance 

Interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | 25 May 2022

The Q&A document aims to clarify some of the overlaps between the Clinical Trials for Medicinal Products for Human Use (CTR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Clinical trial experts from the Clinical Trials Facilitation and Coordination Group (CTFG) and in vitro diagnostics experts from the Medical Device Coordination Group (MDCG) collaborated on it. Clinical trial assays can range from CE-marked in vitro diagnostic medical devices (IVDs) to trial- or medicinal product-specific assays that aren’t necessarily aimed at becoming IVDs. This document and the idea of the “medical purpose of an assay in a clinical trial” as a specific context were born out of the necessity to define criteria for these tests.

Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices | 24 May 2022

Switzerland has participated in the European Union’s internal market for in vitro diagnostic medical devices through the EU-Switzerland Mutual Recognition Agreement’s medical devices chapter (MRA). The MRA’s medical devices chapter allows the European Union and Switzerland to recognise conformity assessment certificates based on the equivalence of Directive 98/79/EC on in vitro diagnostic medical devices and Swiss legislation. The parties have been able to trade in vitro diagnostic medical equipment more quickly. 

On 26 May 2022, the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices replaced Directive 98/79/EC. In the absence of an MRA update to incorporate Regulation (EU) 2017/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceases to apply as of 26 May 2022. 

Application of IVDR requirements to ‘legacy devices’ and to devices placed on the market before 26 May 2022 | 20 May 2022

The document provides information on the application of IVDR regulations to ‘legacy devices’ and ‘old’ devices since Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), specifically Article 110(3).

Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 20 May 2022

The Q&A documentcovers the concerns about the Unique Device Identification system (UDI system), which was established by Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The document intends to give economic operators more information on applying and implementing the UDI requirements.

Summary of Safety and Performance template | 20 May 2022

For class C and D devices, other than devices for performance studies, IVD Regulation (EU) 2017/746 requires the manufacturer to prepare a Summary of Safety and Performance (SSP), which provides public access to an up-to-date summary of the main aspects of the safety and performance of the device. A notified body (NB) must confirm the SSP before it may be made public via the European database on medical devices (EUDAMED). The template can be found here.

New publication of Harmonised standards under the medical devices Regulations | 17 May 2022

The European Commission issued a decision on 11 May 2022, amending the relationship between harmonised criteria for quality management systems, sterilisation, and risk management applications in medical devices. The annex to implementing decision is amended as follows:

  • Entry 10 is replaced by EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
  • EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021
  • The following standards have been added:
  • EN 285:2015+A1:2021 – Sterilisation – Steam sterilisers – Large sterilisers
  • EN ISO 14971:2019 – Medical devices – Application of risk management to medical devices (ISO 14971:2019)
  • EN ISO 14971:2019/A11:2021

Significant changes regarding the transitional provision under Article 110(3) of the IVDR | 04 May 2022

This guidance document aims to clarify the idea of ‘significant changes in the design and intended purpose’ as defined by IVDR Article 110. (3). It applies to manufacturers of devices that comply with Directive 98/79/EC and the devices that are placed on the market or put into operation after 26 May 2022 during the transition period, in line with Article 110(3) IVDR, regardless of whether those devices needed notified body involvement under the IVDD.

AUSTRIA

Clinical investigations with medical devices | 25 May 2022

With the implementation of IVD Regulation (EU) 2017/746, which will regulate the performance studies of in vitro diagnostic medical devices, from 26 May 2022, performance studies must therefore be submitted or reported to the BASG for approval using the updated form, following the requirements of the IVDR. For clinical investigations, the valid submission will then be confirmed. The study can be initiated, followed by a 45-day scientific and regulatory review period.

IRELAND

In Vitro Diagnostic Medical Devices Regulation comes into effect in the EU | 26 May 2022

The European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 took effect on 26 May 2022. IVDs are medical devices that use biological samples to do tests to evaluate a person’s health condition. They range from self-tests for pregnancy and blood glucose testing for people with diabetes to complex diagnoses performed in clinical laboratories.

IVDR Transition Timelines | 26 May 2022

The EU Medical Devices Directive 98/79/EC (IVDD) will be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which took effect on 26 May 2022.  The existing transitional timeframes for devices set out in Article 113 of the IVDR are extended by this amendment. The IVDR classification will determine the length of the transition. By 26 May 2022, self-declared IVDs that will not be classified under the IVDR must be IVDR compliant. Below are the transition timelines:

IVDR ClassificationIt may be placed on the market untilCan continue to be made available until
Class D26 May 202526 May 2026
Class C26 May 202626 May 2027
Class B26 May 202726 May 2028
Class A (sterile)26 May 202726 May 2028

In-House Manufactured Devices (IHM) – IVDR Article 5 | 26 May 2022

Article 5(5) of the IVDR outlines the precise criteria and duties that apply to health institutions that manufacture and use IVDs in-house, as long as the device is not transferred to another legal entity. From 26 May 2022, IHM devices will be subject to the general safety and performance criteria outlined in Annex I of the IVDR. However, Regulation 2022/112 defers several IHM device requirements, which are listed in the table below:

IVDR requirementsDescriptionApplicable From
Article 5(5) and Annex IAnnex I applies to in house manufactured devices.26 May 2022
Article 5(5) b, c, and e-iSee Art 5(5) for further details.26 May 2024
Article 5(5)dThe requirement to justify that a patient group’s specific needs cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market.26 May 2028
Article 5(5) final paragraphMember States’ rights to request information/restrict the manufacture and use of devices and inspect health institutions.26 May 2022

HPRA Decision Tree – IVDR Performance Study | 26 May 2022

A decision tree for IVDR performance studies was created to help sponsors determine whether IVDR regulations apply to their research, such as whether an application or notification is necessary. Refer to IVDR Chapter VI for more details.

IVDR Registration Requirements | 26 May 2022

The usage of the EUDAMED database to meet registration obligations is recognised by HPRA. Article 28 of the IVDR outlines the responsibilities of manufacturers, authorised representatives, and importers. To comply with the registration duties, Irish economic operators are encouraged to use the EUDAMED’s actor registration module. By completing the online registration form, distributors, health institutions, and production facilities can register with HPRA.

CZECH REPUBLIC

Information systems in the field of regulation of medical devices | 19 May 2022

The National Medical Device Information System (NISZP) published a document outlining the information systems utilised in the Czech Republic and the European Union to regulate medical devices. The document conveys the following information:

  • the current medical device regulation in the Czech Republic,
  • EUDAMED Database, its modules, and the deadlines
  • UDI
  • Agendas of the Medical Device Information System (ISZP)

The Czech version of the document can be found here.

European Commission implementing decisions on harmonised standards for medical devices published in the Official Journal of the European Union | 17 May 2022

The National Medical Device Information System (NISZP) issued the Czech versions of the EU’s decisions:

  • 2022/729 of 11 May 2022 amending Implementing Decision (EU) 2021/1195 related to the standards for the quality management systems, and the application of risk management to medical devices

2022/757 of 11 May 2022 amending Implementing Decision (EU) 2021/1182 related to the standards for quality management systems, sterilisation, and risk management application to medical devices

FRANCE

European guideline on borderline products | 19 May 2022

Medical Device Coordination Group (MDCG) published guidance for the Borderline Products (Medical Devices and Medicinal Products). Borderline products are those for which it is unsure whether they fall under the MDR or the MPD from the beginning. EU Regulation 2017/745 is used for governing the medical devices in the EU. In contrast, Directive 2001/83/EC regulates the medicinal products for human use (MPD). This document clarifies these regulations with additional explanations and examples to promote the MDR’s consistent application. The publication provides definitions and examples and sections on substance-based devices, plant-based goods, and drug-medical device combinations.

Cosmetics – Production communication | 19 May 2022

Manufacturers of cosmetics shall communicate cosmetics production to the Ministry, either on their own or on behalf of third parties, using the new form made accessible, including extemporaneous manufacturing and small quantities.

Establishment of the national network for supervision | 02 May 2022

The decree for establishing the national network for supervision was published in the official gazette. According to current legislation, public and private health professionals must immediately report any significant accident to the Ministry of Health and the device’s manufacturer. The Ministry of Health then oversees the investigations conducted by the manufacturer or his authorised representative, analysing and monitoring the effectiveness of the corrective actions made. The network was set up to make it easier to share information on events and safety actions involving medical devices, in vitro diagnostic medical devices, and equipment included in Annex XIV of Regulation (EU) 2017/745. The surveillance system is maintained by continuously monitoring medical equipment incidences after being placed on the market. This information system gathers data on the following topics:

  • local supervisor and regional manager contact information
  • incident reports created by healthcare professionals
  • extracts from incident reports provided by manufacturers
  • security measures

RUSSIA

Roszdravnadzor gave recommendations on the operation and use of medical devices connected to the Internet | 19 May 2022

If a medical organisation lacks the resources to employ a secure data transmission network, the medical device must either operate as part of a separated technical network or data should be sent between various components of medical devices employing portable data storage devices. Furthermore, Roszdravnadzor stated that before upgrading the software on a medical device, it is required to ensure the development of backup copies of the software so that it may be restored to its initial state.

Resumption of supplies of imported X-ray film to the Russian Federation | 16 May 2022

The Federal Service for Surveillance in Healthcare held a working meeting with authorised representatives of foreign manufacturers of X-ray film. The daily monitoring of Roszdravnadzor in the country’s regions recorded the defector of this medical product due to the search for new logistics routes by film manufacturers.

The Ministry of Health will study the issue of lifting the ban on the export of medical equipment abroad | 16 May 2022

The Ministry of Health of Russia is working on the issue of lifting the ban on the export of medical equipment from the country for repair as per the First Deputy Minister of Health of Russia, Viktor Fisenko. He highlighted that it is sometimes necessary to export equipment or components for repair overseas. The lifting of such limitations is now being discussed with the Ministry of Economic Development and Roszdravnadzor.

Russia will create a digital service for online medical consultations | 16 May 2022

GLONASS JSC and Polymed will create a telemedicine platform GLONASS Zabota for online consultations with medical specialists, a wide range of laboratory tests, and the order of medicines. This platform will enhance the number of laboratory tests available to citizens of all Russian regions, including those in remote areas, both at stationary and mobile locations with home visits. The service’s users will be able to send the study results to any polyclinic in Russia. Secure data transmission channels of the era-GLONASS state information system will offer the legal meaning of the information, allowing test results to be verified and uploaded to the Unified State Information System in healthcare.

Import substitution in the market of dental materials | 16 May 2022

90% of supplies, tools, and equipment used in private dentistry come from foreign manufacturers. Still, many transactions have become unfeasible due to recent anti-Russian sanctions and logistical issues. Consumables such as dental fillings, braces, mouthguards, and other items have also increased in price. According to experts, Russia has its production. It may replace items from Europe and the United States by refocusing on the Southeast Asian, Chinese, and South Korean markets.

Increase in the production of domestic medical equipment| 12 May 2022

Manufacturers should be aware that, to expand the line and bring domestic products to market as quickly as possible, Roszdravnadzor must reduce the time it takes to issue registration certificates for medical devices, as well as the issuance of certificates of origin of goods and acts of expertise by the Chamber of Commerce and Industry of Russia (CCI). At the same time, medical equipment are already eligible for faster registration under a government directive.

UNITED KINGDOM

Notify the MHRA about a clinical investigation for a medical device | 19 May 2022

All deviations from the study must be reported to the MHRA as soon as the manufacturer becomes aware of them. Details concerning the nature of the deviation, when and where it happened, and any recommended corrective and preventative activities, should be included using the ‘live’ excel template for submitting.

Joint Statement on the launch of the negotiations for a Free Trade Agreement between the UK and Mexico | 20 May 2022

On 20 May 2022, Tatiana Clouthier, Secretary of Economy of the United Mexican States, and Anne-Marie Trevelyan, Secretary of State for the United Kingdom’s Department for International Trade, met in London. They announced the beginning of negotiation for a Free Trade Agreement between the United Mexican States and the United Kingdom in a joint statement. The first official round of the talks will occur in Mexico City in July 2022, followed by a second round in the autumn. This agreement will improve investment flows, strengthen trade in products and services, and encourage digital and cross-border trade.

SWITZERLAND

New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022 | 26 May 2022

The Federal Council adopted the new In-vitro Diagnostic Medical Devices Ordinance (IvDO) and an amendment to the Ordinance on Clinical Trials (CTO-MedD) with Medical Devices on 04 May 2022. The new legal requirements take effect on 26 May 2022, coinciding with the EU’s implementation of the IVDR. Clinical trials with in vitro diagnostic medical devices will be governed by the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) beginning on 26 May 2022, rather than the Ordinance on Clinical Trials (ClinO).

New rules for performance studies | 26 May 2022

Except for performance studies, the provisions of ClinO-MD apply to all performance studies as of 26 May 2022. To assess if a study project must be submitted to Swissmedic, a decision tree for categorising performance studies has been made accessible. Swissmedic and the competent cantonal ethics council must additionally approve performance studies based on this decision tree.

Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices | 25 May 2022

Switzerland has previously participated in the European Union’s internal market for in vitro diagnostic medical equipment under the medical devices chapter of the EU Switzerland Mutual Recognition Agreement (MRA). The medical devices chapter of the MRA provides the acceptance of conformity assessment certificates between the European Union and Switzerland based on the equivalence of Directive 98/79/EC and the applicable Swiss law. However, with the introduction of the new IVD Regulation (EU) 2017/746, the MRA has become obsolete from 26 May 2022, resulting in the following consequences:

  • Swiss in vitro diagnostic medical device manufacturers will be classified as third country manufacturers in the European Union (EU)
  • Conformity assessment bodies established in the EU must certify the conformity assessment procedure
  • Certificates issued under the MRA by Swiss conformity assessment organisations will no longer be recognised as valid in the EU, even if granted before 26 May 2022
  • Swiss manufacturers and third country manufacturers must designate an authorised representative established in the EU for placing the devices on the EU market after 26 May 2022

Medtech in Switzerland 2030 | 17 May 2022

On 17 May 2022, Swiss Medtech announced its vision for “Medtech in Switzerland 2030”, describing methods to maintain Switzerland’s appeal as a Medtech company destination in the future. Stable trade ties, open markets, innovation promotion, and reimbursement schemes tailored explicitly to the Medtech industry were discussed. The reform agenda is essential since the failure of institutional agreement discussions between Switzerland and the European Union (EU) has affected business competitiveness.

Approval of medical devices according to non-European regulatory systems | 06 May 2022

Switzerland only accepts medical devices for national supply that are CE marked and comply with the European Union’s (EU) medical device regulation. Additionally, Switzerland also accepts medical devices from non-European regulatory systems. This is especially true for medical devices that have been approved by the US Food and Drug Administration (FDA).

AUSTRALIA

Seasonal Influenza Rapid Antigen Self-tests and Combination tests | 27 May 2022

The document’s goal is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration’s (TGA) expectations for clinical performance requirements (clinical sensitivity and specificity) and risk mitigation for in vitro diagnostic medical devices (IVDs) intended for use as self-tests for seasonal influenza and combination tests (for both COVID-19 and Influenza).

Personalised medical device framework | 20 May 2022

TGA uploaded a presentation on the medical device regulations’ overview.

Regulation of software-based medical devices | 03 May 2022

TGA provided provisional guidance to assist manufacturers and sponsors in understanding how the TGA interprets regulations and indicates how they can comply.

Unique Device Identification | 02 May 2022

TGA held a webinar for the Unique Device Identification on 19 April 2022. The presentation of the webinar #8 can be found here. TGA has been undertaking series of webinars on the UDI topics since 2021.

UNITED STATES OF AMERICA (USA)

Revocation of Authorisation of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19 | 24 May 2022

The FDA granted the Broad Institute an Emergency Use Authorization (EUA) for the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay on 08 July 2020, subject to the provisions of the Authorisation. Later, on 04 April 2022, the institution requested revocation from the FDA.

Feasibility and early feasibility clinical studies for specific medical devices intended to therapeutically improve glycemic control in patients with type 2 diabetes mellitus | 06 May 2022

T2DM (Type 2 Diabetes Mellitus) is a metabolic condition characterised by high blood sugar levels, insulin resistance, and insulin deficiency. As a result, several medical device manufacturers and researchers are working to create therapeutic medical devices, including blood glucose monitors and insulin pens, pumps, and syringes, to help patients with T2DM improve their glycemic control. The FDA released a guidance document outlining its initial thoughts on feasibility and early feasibility clinical investigations for these medical devices. These medical devices are designed to lower glycated haemoglobin (HbA1c) levels in T2DM patients without using medications like insulin. Manufacturers are encouraged to submit a Pre-Submission to obtain detailed feedback on the clinical investigation of medical devices within the scope of this guidance that are intended to therapeutically improve glycemic control in patients with T2DM before initiating a pivotal clinical study or to receive additional feedback on the feasibility study design before starting a crucial clinical study.

Voluntary medical device manufacturing and product quality pilot program | 05 May 2022

In 2018, the FDA and the Medical Device Innovation Consortium (MDIC) conducted a voluntary pilot programme among medical device manufacturing sites. MDIC program activities and operations are moving into a permanent program, termed the Case for Quality Voluntary Improvement Program (CfQVIP), based on the pilot’s success. In preparation for the transition to a permanent programme, the FDA and MDIC cooperated to create a charter and a governing committee for CfQVIP. The FDA is currently developing a complementary policy for engaging with CfQVIP. When adopted, this FDA regulation will be based on the FDA’s experience with the Voluntary Medical Device Manufacturing and Product Quality Pilot Program.

Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions during the coronavirus disease 2019 (Covid-19) public health emergency | 04 May 2022

The FDA issued a guidance document to give the policy to help address existing manufacturing limits or supply chain concerns due to the public health emergency created by COVID-19.

BAHRAIN

Assigning a Post marker surveillance officer | 12 May 2022

As part of the NHRA’s role in ensuring the safety of medical devices in the post-market phase, all healthcare facilities and authorised representatives are strongly encouraged to appoint a PMS officer who is responsible for medical device reporting in the post-market surveillance stage, including field safety notices, adverse events, and complaint reporting to the NHRA.

INDIA

Insertion of rule 43A in MDR 2017 for suspension and cancellation of license | 18 May 2022

The Ministry of Health and Family Welfare has released a Notification to the Official Gazette to amend the Medical Devices Rules 2017. Following consultation with the Drugs Technical Advisory Board and in the exercise of the powers provided by sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the Central Government applies the following regulations to modify the Medical Devices Rules, 2017:

  • These rules may be called the Medical Devices (Third Amendment) Rules, 2022
  • They will take effect on the day they are published in the Official Gazette.
  • Rule 43A – Suspension and cancellation of license for the entity failing to comply with the conditions of an Import License

PAKISTAN

Amendments in the Medical Devices Rules, 2017| 18 May 2022

On 27 April 2022, the Drug Regulatory Authority of Pakistan (DRAP) received approval from the Federal Government to amend the Medical Devices Rules, 2017. The document can be found here.

April Newsletter

AUSTRALIA

Transitioning to the new Therapeutic Goods Advertising Code | 05 April 2022

The Therapeutic Goods Administration (TGA) is updating advertisers on the transitional arrangements for the 2021 Advertising Code, particularly regarding hard copy ad stock.

On January 1, 2022, the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021 Code) went into effect. The Therapeutic Goods Advertising Code (No. 2) 2018 is repealed and replaced by the 2021 Code (2018 Code). Advertisers can comply with either the 2021 Code or the 2018 Code during the transition period, which runs through June 30, 2022.

In comparison to the 2018 Code, the mandatory statement requirements in the 2021 Code have been streamlined and decreased in number. However, the TGA recognises that advertisers may have hard copy advertisements on hand that meet the 2018 Code’s statutory statement requirements but are not strictly compliant with the 2021 Code. While marketers use up their existing hard copy inventory, the TGA will take a pragmatic approach and refrain from taking enforcement action when advertisers follow the 2018 Code’s mandatory statement requirements rather than the 2021 Code’s. The TGA expects marketers to move to the 2021 Code requirements by the end of the transition period on 30 June 2022 for advertising that can be easily altered.

UNITED STATES OF AMERICA (USA)

Counterfeit At-Home OTC COVID-19 Diagnostic Tests | 29 April 2022

Counterfeit COVID-19 tests are tests that have not been authorised, cleared, or approved by the FDA for distribution or use in the United States but are designed to appear like authorised tests so that consumers believe they are actual FDA-approved tests. The FDA is worried about the possibility of erroneous findings when consumers use these illegal tests since the performance of these bogus tests has not been thoroughly proven. The FDA has a list of authorized at-home OTC COVID-19 diagnostic tests.

Resilient Supply Chain Program for Medical Devices| 20 April 2022

The Resilient Supply Chain Program (RSCP) for medical devices aims to strengthen public health supply chains by proactively monitoring, assessing, and communicating risks and vulnerabilities to minimise medical device shortages.

The RSCP was created to improve the FDA’s ability to prevent and mitigate supply chain disruptions and promote resiliency in the US medical device supply chain to ensure that patients have access to safe and effective medical devices by: 

  • Developing strategies, analyses, and informational products to prevent and, when appropriate, mitigate medical device supply chain disruptions and shortages
  • Identifying supply chain hazards and disseminating actionable information to medical device manufacturers, distributors, healthcare delivery organisations, patients, healthcare employees, and government partners. Developing communication channels across the medical device ecosystem to enhance collaborations for the development of prevention and risk reduction strategies 
  • Enhancing collaborations for the development of prevention and risk reduction strategies by developing communication channels across the medical device ecosystem 
  • Working with government partners and medical device stakeholders to evaluate supply chain disruption and shortage signals, assess potential consequences, and provide public health data to assist an informed response.

Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication | 19 April 2022

The Food and Drug Administration (FDA) in the United States is alerting consumers and healthcare providers about the dangers of misleading results from genetic non-invasive prenatal screening (NIPS) tests, also known as non-invasive prenatal testing or tests (NIPT). NIPS tests can reveal whether a foetus has specific genetic abnormalities that could lead to a child being born with a severe health problem.

The FDA is providing this information to educate patients and health care providers and assist limit the improper use of NIPS testing due to the increased usage of these tests and concerns raised in recent media stories. Before electing to receive NIPS tests, the FDA suggests that patients talk to a genetic counsellor or other health care provider about the benefits and dangers. Before making any decisions concerning their pregnancy, patients should review the results of NIPS tests with a genetic counsellor or other health care practitioner. These screening tests have dangers and limits, and the results should not be used to identify chromosomal (congenital) abnormalities or illnesses on their own.

Breakthrough Devices Program | 15 April 2022

The Breakthrough Devices Program is a voluntary programme that recognises specific medical devices and device-led combination solutions that improve the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The FDA’s Breakthrough Devices Program allows manufacturers to interact with FDA experts through various programme options, allowing them to address issues that arise during the premarket review phase quickly. This programme can help manufacturers receive feedback from the FDA and identify areas of agreement. Manufacturers might also expect their submission to be reviewed first.

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | 07 April 2022

FDA Released draft guidance that applies to devices that incorporate software (including firmware) or programmable circuitry, as well as software as a medical device (SaMD). The guidance is not restricted to network-enabled devices or have other linked features. The guidance offers suggestions for cybersecurity information to be supplied for devices under the following premarket submission categories:

  • Premarket Notification (510(k)) submissions
  • De Novo requests
  • Premarket Approval Applications (PMAs) and PMA supplements
  • Product Development Protocols (PDPs)
  • Investigational Device Exemption (IDE) submissions
  • Humanitarian Device Exemption (HDE) submissions

The document can be found here.

Medical Device Interoperability | 05 April 2022

Medical device interoperability refers to the capacity to share and use data between one or more devices, products, technologies, or systems in a safe, secure, and efficient manner. This data can be displayed, stored, interpreted, analysed, and utilised to automatically act on or control another product, among other things.

As electronic medical devices grow more connected to one another and other technologies, the capacity of interconnected systems to share and use data safely, securely, and effectively becomes increasingly essential.

Interoperable devices that can communicate data across systems and platforms can help to improve patient care, reduce errors and adverse events, promote innovation, and enable more diversified study datasets.

The FDA encourages intelligent, secure, and safe interoperability between medical devices and information systems. To promote medical device interoperability, the agency has worked with hospitals, health care providers, manufacturers, standards development organisations, and other interested parties. 

EUROPEAN UNION (EU)

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | 26 April 2022

The difference between Regulation (EU) 2017/745 on medical devices (MDR) and Directive 2001/83/EC on medicinal goods for human use (MPD) is critical for the appropriate implementation, interpretation, and enforcement of the two sets of laws.

Several sections in the MDR and MPD serve as a separating line between the two legal frameworks. This guidance document includes further clarifications and examples of essential regulations to aid in the uniform implementation of the MDR across the EU. A working group of experts from Member States’ relevant agencies, Commission services, the European Medicines Agency, and various stakeholders prepared the document.

Clinical Trials Regulation Question and Answer document | 13 April 2022

European Commission has released a question-and-answer document on Clinical Trials Regulation (EU) 536/2014. The goal of the paper is to provide answers to clinical trial-related issues. This article contains commonly requested ‘questions and answers about how the rules on clinical trials are implemented. All revisions to these questions and answers are given and debated by the “Expert group on clinical trials” and reflect the group’s viewpoint. The document can be accessed here.

EUDAMED – UDI/Devices technical documentation update | 11 April 2022

Regulations (EU) 2017/745 and 2017/746 introduced the EU device identification system based on a unique device identifier (UDI), allowing medical devices traceability. This requires that manufacturers submit the UDI/Device information of all devices they place on the EU market in EUDAMED. The document clarifies the data provided in EUDAMED for the UDI module.

EUDAMED – NBs & Certificates module technical documentation update | 11 April 2022

Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn, or refused and other restrictions imposed on these certificates. Such information is accessible to the public. The document clarifies the update in the EUDAMED NB & certificates module.

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | 01 April 2022

The IVDR (In-Vitro Diagnostic Medical Devices Regulations) is set to effect on 26 May 2022. The Medical Device Coordination Group (MDCG), which comprises experts appointed by the Member States, approved a Joint Implementation Plan for the MDR in March 2020. Priority activities for Member States and Commission services were outlined in the plan, which would be monitored at the MDCG level. The MDR joint implementation plan acknowledged a similar process for the IVDR. As a result, the present document proposes a draft IVDR joint implementation plan. The document was updated this month.

ITALY

Report on surveillance activities 2020 | 08 April 2022

The report outlines the medical device and in vitro diagnostic medical device monitoring operations carried out during 2020. The report analyses the data collected in the Ministry’s supervisory system database based on health professionals’ and manufacturers’ recommendations. The publication is aimed at all stakeholders in the device sector, including manufacturers, healthcare professionals, patient associations, and central and local institutions interested in purchasing and managing medical devices and in vitro medical-diagnostic devices. It allows the reader to acquire helpful information elements to carry out better their professional activity in medical devices and in vitro medical-diagnostic devices that have already been placed on the market. The Italian report can be found here.

IRELAND

Webinar – In-Vitro Diagnostic Medical Devices Regulation | 21 April 2022

The HPRA (Health Products Regulatory Authority) will host a free webinar on the In-Vitro Diagnostic Medical Devices Regulation (IVDR), which will address significant subjects and provide practical information on the IVDR’s implementation, regulatory implementation at the national and European levels, post-market surveillance, vigilance and registration requirements, and HPRA inspections and performance studies. For registration, visit here.

Annual Communication | 21 April 2022

If the synthetic methods, processing equipment, cleaning or containment procedures are comparable to active substances, HPRA has published a form for the manufacturer, importer, or distributor of active substances to add new active substances to the registration.

Medical Device Regulation: Survey for healthcare professionals | 25 April 2022

The Health Products Regulatory Authority (HPRA) is surveying to assess healthcare professionals’ awareness and understanding of medical device (MD) and in vitro diagnostic medical device (IVD) laws in Ireland. This survey’s results will only be used to identify particular regulatory subjects of concern to healthcare professionals and determine how to effectively help them with medical devices and IVD regulations. The survey can be found here, and the deadline to submit it is 13 May 2022.

MALTA

Self-Test COVID-19 Kits | 15 April 2022

The Malta Medicines Authority has released applications inviting distributors to submit applications to make Covid-19 Self-Test Kits available to the public.

POLAND

Introduction of robotic surgery to the public health system | 08 April 2022

Health Minister Adam Niedzielski launched the introduction of robotic surgery into Poland’s public healthcare system.  The financing of robotic surgery procedures is a technological leap in Polish healthcare; all operations will be reimbursed according to a specially calculated tariff, said Adam Niedzielski at the Provincial Specialist Hospital in Wrocław during a conference on the development and financing of robotics inpatient treatment. – On the one hand, robots make doctors’ jobs simpler, and on the other hand, it ensures that patients receive the best possible care’ he added further.

UNITED KINGDOM (UK)

Written Confirmations for export to EEA and Northern Ireland of Active Substances manufactured in Great Britain | 04 April 2022

The United Kingdom is designated as a Third Country to export Active Substances for Human Use to the European Economic Area (EEA). Northern Ireland’s active substance manufacturers will continue to be accepted by the European Economic Area. Each shipment of Active Substance manufactured in the UK exported to the EEA, and Northern Ireland will then require a Written Confirmation. For the Written Confirmation, a template has been created here. This Written Confirmation certifies the following for a third nation exporting Active Substances to the EEA:

  • the standards of Good Manufacturing Practice (GMP) are equivalent to those in the EU/EEA
  • the manufacturing plant is subject to regular inspections (which may be both announced and unannounced)
  • significant non-compliance events would be communicated to the EEA without delay

BRAZIL

Import of goods and products under sanitary surveillance | 20 April 2022

ANVISA issued a Notice inviting any individual or institution interested in the topic to provide data and information to identify difficulties encountered in the import procedures of goods and products subject to sanitary monitoring. The implementation of laws for international trade activities should consider the promotion of product access and the reduction of the health risk of these items to the Brazilian population. Any person or organisation interested in the issue is welcome to participate in the consultation, particularly those involved in foreign commerce, such as importers, exporters, customs brokers, carriers, customs, and representatives from other federal agencies. Those interested in taking part must complete the survey between 26 April 2022 and 09 June 2022.

ANVISA discloses data on adverse events | 07 April 2022

The 1st Newsletter on Post-Market Monitoring of products and services subject to health surveillance has been released by ANVISA. Based on data from the System of Notification and Investigation in Sanitary Surveillance, the publication includes information on notifications of adverse events, technical complaints, product quality deviations, and reports of intoxications. The data covers poisoning, Surveillance and Control Measures, Cannabidiol, Kit Intubation, Sanitizing, and Cosmetovigilance.

Implantable defibrillators and cardiac valve prostheses | 01 April 2022

ANVISA issued Call Notices 5 and 6 in the Official Gazette (D.O.U.) requesting holders of registrations for implanted defibrillators and cardiac valve prosthesis, which follow the technical qualities specified in Normative Instruction (IN) 119/2022 and having the following technical names:

  • Implantable double chamber defibrillator
  • Single-chamber implantable defibrillator
  • Implantable defibrillator for cardiac resynchronization therapy
  • Biological cardiac valve prosthesis
  • Mechanical cardiac valve prosthesis

to send technical attributes of each model of medical device (health product) registered with ANVISA for economic monitoring purposes in a spreadsheet. The technical attribute data collected will be used to create economic monitoring panels for implantable defibrillators and cardiac valve prostheses, which will enable the grouping of products with similar technical specifications and the disclosure of price history statistics used in public purchases, reducing asymmetric information in the market.

OMAN

MOH Gains ISO International Recognition | 13 April 2022

The Ministry of Health, represented by the Directorate General of Quality Assurance Center (DGQAC), was awarded ISO 9001/ 2015 certification by the International Organization for Standardization in 2020 for the following directorates:

  • The Directorate General of Administrative Affairs
  • The Directorate General of Financial Affairs
  • The Directorate General of Pharmaceutical Affairs & Drug Control
  • The Directorate General of Private Health Institutions
  • The Directorate General of Projects & Engineering Affairs

SINGAPORE

Guidance on Change Notification for Registered Medical Devices | April 2022

This guideline document aims to assist registrants in assessing whether a Change Notification for a medical device listed on the Singapore Medical Device Register (SMDR) is required. Registrants must inform the Authority about the modifications of the registered medical devices under the Health Products (Medical Devices) Regulations 2010 (Regulations). As a consequence of a reportable Adverse Event (AE) or an ongoing Field Safety Corrective Action, this guidance also applies to circumstances where a registered device undergoes any adjustments or planned changes, including labelling changes (FSCA). The guidance document can be accessed here.

Software Medical Devices – A Life Cycle Approach | April 2022

This guideline is produced by the Health Sciences Authority (HSA) to clarify the regulatory obligations for software medical devices across their entire life cycle, from product development through post-market activities following their launch in Singapore. This guideline is only a recommendation. It should not be interpreted as a new regulatory control on software medical devices by anyone involved in developing and providing such devices in Singapore. This paper addresses essential software-related regulatory requirements, such as cybersecurity and regulations for Artificial Intelligence (AI) medical devices, and it applies to the software of all Risk Classifications. With new software-related technologies and growing hazards, these rules will be evaluated and updated regularly. The document can be found here.

Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) | April 2022

To establish the risk categorization of Standalone Medical Mobile Applications that are Medical Devices, this guideline refers to the IMDRF’s Framework for Software as a Medical Device (SaMD) (commonly referred to as SaMD). This guideline further clarifies whether Clinical Decision Support Software (CDSS) is classified as a regulated medical device or not and the current regulatory approach and standards for such software regulated by HSA. The guideline can be found here.

HSA’s advisory on factors that may affect the accuracy of COVID-19 antigen rapid self-test kit results | 04 April 2022

COVID-19 testing, including polymerase chain reaction (PCR) testing and antigen rapid tests (ART), are helpful tools for detecting COVID-19 infection. While professional PCR tests and ARTs performed by healthcare professionals are assumed to have greater precision, self-testing remains an essential tool in public health response during a pandemic because it is easily accessible, inexpensive, and provides faster results in the detection of COVID-19. The Health Sciences Authority (HSA) has evaluated all COVID-19 ART self-test kits to fulfil the required safety, performance, and quality requirements. However, the test findings may be influenced by a variety of circumstances, including the viral load of the individual and the sampling method used. Companies must notify HSA of any erroneous findings from their ARTs that they are aware of, and HSA must investigate to rule out any quality or performance concerns with their tests. HSA is actively watching local and worldwide trends and will take appropriate measures if necessary.

Guidance – Special Access Routes (SAR) | 01 April 2022

All Class B, C, and D medical devices must be registered with the Health Products Act (Act) and the Health Products (Medical Devices) Regulations 2010 (Regulations) before being sold in Singapore. Qualified practitioners (i.e., physicians and dentists) sometimes need access to unregistered medical devices to fulfil exceptional clinical needs emerging in their profession in an emergency or when all conventional treatments have failed. Qualified practitioners may use unique access methods to access unregistered medical devices for use on their patients. More details can be found here.

Note: The Special Access Routes (SAR) updates for unregistered medical devices will take effect from 1 April 2022.

Webinar – Dental Laboratory Regulatory Requirements in Singapore | 01 April 2022

The Singapore Health Sciences Authority will have a Zoom webinar to discuss the regulatory standards for dental laboratories that manufacture or modify dental devices. The regulatory obligations that apply to dental laboratories that manufacture devices for local use and guidance on the notification and reporting processes will be covered in this webinar. For more details and registration, visit.

PAKISTAN

DRAP issues final Guidance document for applicants on Import and Export permissions of therapeutic goods in the country | 27 April 2022

DRAP has regulatory control over the import and export of all therapeutic products to evaluate if they are permissible under relevant drug laws and prohibits entrance or exit of any therapeutic commodity if the regulatory standards are not met. These regulatory measures are in place to prevent substandard therapeutic products from entering the market and to ensure that standard quality therapeutic goods are available. These regulatory controls are in place to keep inferior products out of the supply chain and ensure that standard quality therapeutic commodities are available. The document can be accessed here.

March Newsletter

AUSTRALIA

Consumer/Patient information materials requirements | 02 March 2022

On 26 October 2017, the Australian government passed laws requiring implanted and active implantable medical devices to include patient information materials (patient information booklets and patient implant cards). More flexibility in information delivery was introduced by providing electronic formats. Manufacturers of all implanted devices in the ARTG (Australian Register of Therapeutic Goods), excluding those exempts, have been required to provide patient education materials since 1 December 2021. To be regarded as compliant, patient education materials must follow the Essential Principles; else, the sponsors must ask for permission who want to import, supply, or export medical devices that don’t follow the Essential Principles.

UNITED STATES OF AMERICA (USA)

Mitigating and preventing medical device shortages | 17 March 2022

There have been shortages of different medical devices throughout the epidemic that are vital to public health and safety. To deal with these shortages, the FDA’s Center for Devices and Radiological Health (CDRH) obtained additional statutory power in 2020, according to the CARES Act, to reduce and avoid device shortages during or after a public health emergency. The CARES Act mandated certain medical device makers to report product availability and any significant supply chain interruptions to the FDA. CDRH has improved its understanding and monitoring of the intricate web of supply chains that feed the medical device sector, allowing it to be more proactive in preventing issues. The CARES Act’s authorities have resulted in a very productive partnership between CDRH, manufacturers, and other partners to address supply chain risks. For example, the FDA collaborated with manufacturers to plan for faster marketing applications and increase device availability for COVID-19-related products, such as vaccination administration.

Voluntary eSTAR Program | 11 March 2022

eSTAR is a free interactive PDF form that assists submitters of 510(k)s and De Novos in preparing a detailed medical device submission. The form contains:

  • Automation (for example, form construction and autofill)
  • Content and structure that is complementary to Center for Devices and Radiological Health (CDRH) internal review templates
  • Integration of multiple resources (for example, guidances and databases)
  • Guided construction for each submission section
  • Automatic verification

eSTAR programme aims to improve the quality of medical device submissions by assisting submitters in providing excellent, detailed information for the CDRH’s premarket evaluation. The CDRH does not intend to perform a Refuse to Accept (RTA) evaluation for eSTAR submissions due to automated verification.

CANADA

Legislation to increase access to rapid testing across the country receives Royal Assent | 04 March 2022

Bill C-10 – An Act respecting certain measures related to COVID-19 gave Health Canada $2.5 billion in financing and the legal ability to buy and deploy COVID-19 fast testing across the country. With this money, the federal government will ship millions of COVID-19 rapid tests to provinces, territories, and indigenous communities for free during the next three months. The financing also permits Health Canada to continue distributing tests through partners such as the Canadian Red Cross, chambers of commerce, and pharmacies. The Royal Assent of Bill C-10 ensures that everyone in Canada has greater and equal access to fast testing.

Clinical trials for medical devices and drugs relating to COVID-19 regulations | 02 March 2022

These regulations came into effect on 27 February 2022 and were published on 02 March 2022 as a replacement for Interim Order No. 2, which will be expiring on 03 May 2022. The flexibility granted by the interim order is maintained by these Regulations until the framework created by the Clinical Trials Modernization Initiative is in place. The regulations will:

  • Minimize the administrative load
  • Maintain the health and safety criteria for trial participants ensuring the authenticity of trial data
  • Ease to obtain and carry out COVID-19-related clinical studies

BRAZIL

ANVISA reviews and consolidates standards in the Cosmetics and Sanitizing areas | 18 March 2022

On 16 March 2022, ANVISA published new regulations in the Official Gazette of the Union, which review and consolidate standards in the areas of Cosmetics and Sanitising. The regulations will take effect on 01 April 2022 with the aim of removing ambiguity, upgrading the terminology and language of the current legislation, and replacing acts that have lost their significance.

In-Cosmetics, the following RDCs were published:

  • RDC 628/2022: improvement of the legislative technique of RDC 44/2012, which provides the list of dyes allowed for personal care products, cosmetics and perfumes and internalises the GMC Resolution Mercosul 16/2012. 
  • RDC 629/2022: improvement of the legislative technique of RDC 30/2012, which provides sunscreens and multifunctional products in cosmetics and internalises the GMC Resolution Mercosul 08/2011.  
  • RDC 630/2022: improvement of the legislative technique of Resolution 481/1999, which stabs parameters for microbiological control of toiletries, cosmetics and perfumes and internalises GMC Resolution Mercosul 51/1998.

In Sanitizing, the following RDCs were published:

  • RDC 622/2022: improvement of the legislative technique of RDC 52/2009, which provides for the operation of companies specialised in the provision of vector and urban pest control services. 
  • IN 121/2022: improvement of the legislative technique of IN 4/2012, which provides the acceptance criteria of test reports required for analysis of requests for notification and registration of sanitising products.

ANVISA’s approval for self-tests for Covid-19 | 17 March 2022

For the registration of self-testing products on ANVISA, the products are evaluated for safety, performance and compliance with the legal requirements required for tests. Usability of guidelines of the products should be in such a way that the instructions in simple plain language would guide the layperson to use the product correctly.

ANVISA changes electronic import licensing petitioning | 11 March 2022

From 19 March 2022, the subjects available in the contingency plan for the Import Licensing petition will be unavailable. Users will still be able to file secondary petitions for processes that have already started, such as compliance with requirements, amendments, administrative appeals, etc. The petitions for all matters of consent for Import Licensing carried out by companies will no longer be made by the Electronic Import Petition (PEI) system in six stages, to be completed by 31 August 2022. To obtain import approval, stakeholders must first register their requests in the Single Foreign Trade Portal’s Licenses, Permissions, Certificates, and Other Documents (LPCO) module, then follow the procedure in the Solicita System.

ANVISA publishes standard and manual on compassionate use of medical devices| 04 March 2022

The Resolution of the Collegiate Board of Directors (RDC) 608/2022, which deals with the compassionate use of medical devices, was published in the Official Gazette (DOU). The standard governs programmes aimed at assisting patients with a serious disease for which there is no sufficient therapeutic solution in the country. Companies want to offer a medical device that is still in the validation phase and has a favourable benefit-risk ratio to the patient. This still-under-development process for gaining access to medical devices exists in numerous countries. It allows individuals who might benefit from innovative technologies to receive access to these devices that rely on manufacturer initiative and appropriate health control so that the patient may be observed while safely using the device. It’s crucial to note that it is not a clinical study since the information gathered from patients using medical devices in “compassionate use” does not assist the registration of new products but may use in the medical device’s design and clinical assessment.

EUROPE

Update of MDCG 2019-9 Rev.1 Summary of safety and clinical performance | 24 March 2022

As per the Medical Device Regulation (MDR 2017/745), for implanted devices and class III devices other than custom-made or experimental devices, it is mandatory for the manufacturer to prepare a summary of safety and clinical performance (SSCP). A notified body (NB) must validate the SSCP before it may be made public via the European database on medical devices (EUDAMED) to provide an updated summary of the clinical performance and safety of a medical device and improve transparency.

AUSTRIA

Certified SARS-CoV-2 antigen rapid tests | 25 March 2022

A list of Certified self-testing SARS-CoV-2 antigen rapid tests is provided on the Austrian BASG website. A notified body has been involved as an independent conformity assessment body to examine the eligibility of these tests, and a 4-digit number is affixed next to the CE Mark. Manufacturers of approved self-testing kits who sell their products in Austria are required to provide the following information to be on this list:

  • Trade name of the SARS-CoV-2 rapid antigen test
  • Address and name of the manufacturer
  • Address and name of the authorized representative
  • Declaration of conformity and certificate of the notified body
  • Type of sample collection

Clinical investigations with medical devices | 07 March 2022

The Federal Office for Safety in Healthcare published two guidance’s in German pursuant to Regulation (EU) 2017/745 for initial applications and modifications.

IRELAND

European Commission launches public consultation on the targeted revision of the Cosmetic Product Regulation | 30 March 2022

The European Commission has started an online public consultation until 20 June 2022, to gather comments from all relevant stakeholders on the planned amendment of the Cosmetic Product Regulation 1223/2009. The project focuses on various activities and prospective initiatives to improve the efficiency and efficacy of present cosmetic product regulations.

SWITZERLAND

Direct procurement of foreign medical devices by healthcare professionals in Switzerland | 17 March 2022

The Medical Devices Ordinance allows professionals to procure devices directly from foreign lands for use without putting them on the market, with individual professionals and health institutions automatically assuming full functional responsibility, i.e., no Swiss economic operator is responsible for any procedural or safety-related issues, and delivery readiness is solely dependent on the foreign supplier. This guidance document outlines such professional procurement, what responsibilities the personnel must undertake, and how they may outsource procurement duties. There is also information on the potential implications on supply continuity and the potential consequences of non-compliance with legal standards. The document can be accessed here.

Update of the information sheet – Unique identification number (CHRN – Swiss Single Registration Number) | 03 March 2022

The CHRN is a unique identifying number that may be used to identify a Swiss manufacturer, authorised representative, or importer. Swissmedic does not grant CHRNs to companies based outside of Switzerland. This version 2 of the information sheet reflects the amendments in the structure, new essential material insertion, and the document’s renaming.

In-vitro Diagnostic Ordinance Timeline | 22 February 2022

The Swiss authorities proposed the crucial deadlines related to Swiss IvDO.

CZECH REPUBLIC

Notice to exemption holders for antigen tests to diagnose Covid-19 | 03 March 2022

Antigen tests for Covid-19 that were granted a self-testing exemption by the Czech Republic’s Ministry of Health with effect until 30 June 2021, under the provisions of Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic medical devices, can no longer be placed on the market. These tests can be purchased until that date, and their usage is governed by the expiration date printed on the product. If entities want to continue market tests, it is necessary to repeatedly ask the Ministry of Health for an exemption. Suppose an exemption is granted multiple times to an antigen test that has already been notified to the Register of Medical Devices. In that case, the economic operator must submit an application for a change of the medical device, in which he must enter the file number of the newly issued exemption decision in the certificate number field and upload the decision in question to the annex. If the economic operator no longer applies for an exemption, the medical device must be removed from the RZPRO once the exemption has expired. The Institute will remove the medical device from the RZPRO if they do not respond within 30 days of the exemption expiring.

ITALY

Publication of the MDCG guideline 2022-4| 21 March 2022

The document informs notified bodies about the proper procedures for conducting surveillance operations on CE-marked devices in compliance with the Directives, regardless of whether those notified bodies have applied for designation or are designated under the MDR, as long as the relevant authority responsible for notified bodies has the right to and does monitor the notified body’s activities.

Information on procedures for placing surgical masks on the market | 10 March 2022

Manufacturers who wish to keep surgical masks on the market in Italy after 1 April 2022 will have to follow standard medical device regulations. The circular dated 4 March 2022 specifies that masks approved by the exemption that have already been placed on the market can only be accessible until 31 May 2022. It is emphasised in the circular that it will no longer be possible to place CE marked surgical masks which followed Directive 93/42/EEC, on the market after 26 May 2021. The manufacturers who intend to place surgical masks on the market must comply with the Medical Devices Regulation requirements (EU MDR) 2017/745. As per the regulation, the manufacturer must:

  • Prepare the technical documentation complying with the general performance and safety requirements set out in Annex I of the Regulation
  • Present the documents in a clear, structured, straightforward, and easily available manner
  • Include the test methods and results supporting compliance with the specifications
  • Provide tests of bacterial filtration efficiency, respirability, microbial contamination, splash resistance (only in the cases provided, IIR type masks) and biocompatibility
  • Maintain, update and constantly improve the quality management system
  • Register in the European Database of Medical Devices (EUDAMED) once fully operational
  • Establish and update a post-market surveillance system
  • Declare the conformity of their products by drawing up the EU declaration of conformity referred to in Article 19 of the Regulation and affix the CE marking following Annex V

RUSSIA

The electronic form for submitting information | 25 March 2022

The Federal Service of the Russian Federation informed about an application form on the website for the manufacturers, Authorized Representative or a person importing Medical Devices into the Territory of the Russian Federation to submit the information as per the order number 11020 of Roszdravnadzor posted on 25 November 2021.

TANZANIA

Fees and charges regulations, 2021 | 15 March 2022

Tanzania Medicines and Medical Devices Authority (TMDA) has approved the new Regulations for Fees and Charges, 2021, effective from 01 April 2022. The relevant fees for all the services should be transferred through the Government electronic payment system (GePG) after obtaining a Pro-forma invoice from TMDA indicating a payment Control Number.

BAHRAIN

Medical Devices Shelf-Life Guideline | March 2022

National Health Regulatory Authority (NHRA) published a guideline regarding the service life of medical devices. Below aspects are discussed in the guide:

  • Factors influencing shelf-life
  • Variables like storage conditions, transportation, packaging, sterilization, etc.
  • Contents of shelf-life to be included by the manufacturers

Note for all the importers and shop owners of lenses | 03 February 2022

With regards to the medical devices regulations, National Health Regulatory Authority (NHRA) informs all importers and shop owners of medical and cosmetic lenses to verify the lenses and get approval from NHRA, ensuring the quality and safety of health services.

Medical Device Management Guideline | February 2022

National Health Regulatory Authority (NHRA) designed the guidance to assist all NHRA-licensed healthcare institutions in managing Medical Devices throughout their life cycle, including procuring, installing, maintaining, calibrating, and decommissioning.

Medical Devices Labelling Guideline| February 2022

To guide all importers, healthcare facilities and users of medical devices, NHRA published the guideline to realize the importance of labelling medical devices. Labels ensure that the medical devices are used by the end-users as per the devices’ intended use and manufacturer’s instructions, and not another way around. Labellings inform about the:

  • Risks and advantages of the equipment in user-friendly language
  • Proper use and operation of the device with the help of adequate directions.
  • Recognize, store, assemble, and troubleshoot

INDIA

List of Notified Bodies registered with CDSCO under MDR 2017 | 11 March 2022

With the publishment of the Medical Device Regulation under the Drugs and Cosmetic Act for regulating the manufacture, import, sale, and distribution of medical devices, a list of notified bodies registered with the CDSCO to carry out the audits is provided.

PAKISTAN

Notification of Amendments in Form 6A and Form 7A | 29 March 2022

Drug Regulatory Authority of Pakistan (DRAP) notified about the amendments made in the Form 6A and Form 7A of the Medical Devices Rules, 2017. The forms can be accessed here.