June 3, 2020 Regulatory Updates

Medical Devices – Regulatory Updates – June Volume 1

1.The AEMPS extends the deadline until May 25, 2021 for the adequacy of the labeling and the instructions for use of medical devices as a consequence of the changes made by Brexit

On February 1, 2020 the United Kingdom ceased to be considered an EU Member State to become a third country, as contained in the Withdrawal Agreement, ratified by the European Parliament.

From this date a transition period comes into effect that will last until December 31, allowing, for practical purposes, everything to remain the same for medical device companies in both the European Union and the United Kingdom.

In November 2019, the informative note PS, 29/2019 was published establishing a deadline until June 30, 2020 for the adequacy of the labeling and instructions for use of medical devices as a result of changes made as a result of Brexit.

Given the difficulty that this change is causing to companies and considering the consequences derived from the COVID-19 pandemic, which may have made its implementation difficult, the AEMPS has considered extending the deadline established until May 25, 2021, in order that the companies that are in this situation complete the adaptation of the labels and instructions for use of the products to the changes produced.

2.The AEMPS reports the publication of guidelines for companies providing respiratory therapy equipment services

  • The AEMPS Technical Inspection Committee (CTI) has carried out a market control campaign related to companies that supply home respiratory therapy equipment.
  • As a result of this campaign, a document is published with guidelines for these companies to follow.

3.Requirements for combination products (medicinal product with a medical device component)

Switzerland’s continued aim is to achieve equivalence with EU legislation. The entry into force of the revised Swiss medical devices legislation will thus also be deferred by one year, to 26 May 2021. (Also see publication dated 7 May 2020 on the website).

This also affects the new requirements announced in Swissmedic Journal 10/2019 for combination products, which will now also come into force on 26 May 2021.

The relevant documents, such as guidance documents and application forms, will be adapted to the new requirements and made available on the Swissmedic website in good time.

4.Export license for personal protective equipment in the healthcare sector no longer necessary

As of 26 May 2020, it is no longer necessary to apply for an export license for the export of certain items of personal protective equipment, such as facemasks, goggles, and protective clothing, to countries outside the EU.

The requirement for an export license was introduced on 14 March due to a shortage of personal protective equipment in the EU. On 26 April, the license requirement was extended for 30 days. The European Commission recently decided not to again extend the regulation (EU) no. 2020/568 on which the license requirement was based.

5.Effective field safety notices (FSNs): guidance for manufacturers of medical devices

The medical devices regulations state that manufacturers must tell users about corrective actions involving their device as soon as possible using a Field Safety Notice (FSN).

There are existing guidelines for writing and distributing FSNs in the European Commission’s document Medical Devices Vigilance System (MEDDEV 2.12/1 rev.8 section

In this guidance for manufacturers, we provide supplementary information to the MEDDEV and give advice on how to produce and distribute effective FSNs.

6.Temporary regulations regarding language requirements for medical devices

Due to covid-19 and the possible shortage situation that may arise from medical device products, the Medical Products Agency has decided on regulations (HSLF-FS 2020: 29) on temporary regulations regarding language requirements for medical device products.

The regulations regulate requirements for languages to be used in labeling and instructions for medical devices and apply until 31 December 2020.


7.Reminder: UDI Deadline is coming for Class 1 Devices

UDI compliance deadline for Class 1 and Unclassified devices is coming on September 24, 2020 for both labelling and GUDID submissions.

8.Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190037 added)

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

Canada (HC)

9.Notice: Expansion of the medical device Regulatory Enrolment Process (REP) pilot and the scope for transactions sent via the Common Electronic Submissions Gateway (CESG)

The Health Products and Food Branch (HPFB) is pleased to announce that the initial phase of the pilot for the medical device Regulatory Enrolment Process (REP) concluded on March 31, 2020. Assessment of the REP pilot was generally positive and users’ indicated a favorable response to the expansion of the REP for medical device regulatory activities.

Effective immediately, the scope of the REP pilot has been expanded to include private labels. HPFB will be encouraging all medical device companies to take advantage of the opportunity to use the REP and submit their regulatory transactions via the Common Electronic Submissions Gateway (CESG). Transactions sent via the CESG are received by HPFB within minutes, using efficient and secure transmission in comparison to the current courier and email processes.

ASEAN/ Others
Australia (TGA)

10.Regulation of Personal Protective Equipment and COVID-19

In response to COVID-19, there is increasing interest in understanding the regulation of Personal Protective Equipment (PPE) that might be used for therapeutic purposes including face masks, gowns and gloves. The following guidance is designed to provide:

  • An overview of how these products are regulated
  • Information for manufacturers of PPE to help meet regulatory obligations
  • Information about including a medical device on the Australian Register of Therapeutic Goods (ARTG)
  • Information for consumers of PPE, including healthcare professionals.

11.Advice on surgical masks and gowns during COVID-19

Information relating to surgical masks and gowns to assist healthcare organizations as they update their operating procedures during the outbreak

12.Regulation of thermometers and other temperature measuring medical devices for COVID-19

Updated to include: temperature measuring devices, such as those used for screening people in public places that include an infrared radiation measurement technique

13.Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG

Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia.

India (CDSCO)

14.Public Notice

On May 22 2020, Advisory Notice regarding voluntary registration of personal protection equipment coveralls at CDSCO and its testing at Labs recognized by Ministry of Textiles.


15.Extension of the validity of certificates

It is hereby noticed that, after reassessing the prevailing situation in the country due to COVID 19 pandemic, the National Medicines Regulatory Authority has decided to extend the validity of certificates of registration and import licenses pertaining to Medicines, Medical Devices, Borderline Products and Cosmetics up to 31st July 2020. The extension is applicable for certificates and licenses expiring after 30th of June 2019.
The decision was taken in order to minimize the movement of people. The decision would be reassessed again on or before 31st July 2020.
As such you are kindly requested to refrain from coming to NMRA premises except for an urgent matter.

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