Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, January 2022

  1. Submissions according to the local medical device regulations of the Eurasian member states are closed, but may reopen

According to the Eurasian agreement on the common principles and rules of circulation of medical devices, 1 January 2022 is the end of the transition period for device registration to move from national to the Eurasian level. 

On 30 December 2021, the Eurasian Economic Commission (EEC) released this protocol (link in Russian) confirming the transition and that all registration dossiers submitted before 31 December 2021 must be reviewed using the original rules. The protocol also confirmed that all medical devices approved locally in Eurasian states before 31 December 2021 could keep their status in the member state until their registration expires. The registrations could also be amended to comply with national rules, which are valid until 31 December 2026.

In January 2022, the Russian medical device regulator Roszdravnadzor announced the closure of submissions for new device registration files complying with the original national regulations. Medical device regulators also published same information in Kazakhstan and Belarus

However, on 24 December 2021, the EEC discussed new changes to the agreement, a potential reopening of submissions, and prolonging the transition period for another year. On 19 January 2022, the EEC published Decree 27 (link in Russian) approving this extension which all Eurasian member states should authorize.

In addition, at the end of December 2021, two amendments to existing Eurasian medical device regulations were released by the EEC: Regulation 144, a revision of EEU rules for device registration and examination (link in Russian), and regulation 146, a new edition of the guidance on clinical trials (link in Russian).

At the end of January 2022 there  still  7 medical device approved on the Eurasian database according to new requirements, while the Russian Regulator was saying about hundreds of new submissions per day according to the national requirements for the end of 2021 and more than 31 thousand medical devices approved  on “old approach”.

  1. Upcoming Deadline for submission of clinical monitoring reports in Russia

According to regulation 1113 (link in Russian) that came into force in January 2021, clinical post-market monitoring is now required for class III medical devices and IIB implantable devices registered in Russia afterJanuary 2021. The regulation also states that devices should be continuously monitored, with annual monitoring reports for three years after the approval date. Guidelines for the structure and content of the reports are provided in annex 5 of the regulation.

The deadline for submission of the first reports is 1 February 2022. 

On 21 January 2021, Roszdrvnadzor published a reminder for medical device manufacturers (link in Russian) and clarified the report submission requirements on paper.

3. Extension of the accelerated approval route for medical products for diagnosing and treating COVID-19

In December 2021, the Russian Government released regulation 2250 (link in Russian) and extended until 1 January 2025 the accelerated approval process for COVID-19 diagnostic and treatment products.

According to regulation 430 (link in Russian), more than 400 such medical devices may be approved via the expedited evaluation route with a limited expiration date for a particular batch.

More than 500 existing registration certificates in the national database issued via this route had their validity extended from 1 January 2022 until 1 January 2025;

In January 2022, the Russian regulator confirmed it is possible to submit these registration files using Russian national (but not Eurasian ) criteria. 

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Thank you for following my blog, which aims to provide timely and clear updates on the development of Russian and Eurasian medical device regulations. You may also be interested in my recent article on the Eurasian medical device regulation model, which will be published in the Journal of Medical Device Regulation in February 2022.

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