March Newsletter: 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.
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
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.
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.
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.
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.
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.
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.
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
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.
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.
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
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.
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.