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).
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.
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).
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.
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.
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.
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.
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.
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.
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 error||Maximum Reporting Timeframe|
|Product recall||10 Days|
|Serious side effects or manufacturing fault||20 days|
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