Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, April 2021

Dear Colleagues, 

Welcome to my monthly review of medical device regulatory changes in Russia and the Eurasian region:


1. Suggestions for Multiple Amendments to Russian Medical Device Regulations

In April 2021, multiple amendments made to Federal Law #323 ‘On health care protection’, related to the regulation of medical devices, were discussed by the Russian parliament. The published draft law (link in Russian) related to this initiative, among others, proposed the following significant changes to Russian medical device regulations:

– to amend the list of cases where medical devices are not subject to state registration;

– to implement the procedure for approving the classification of adverse effects of monitoring the safety of medical devices;

– to clarify the definition of ‘poor quality medical device’;

– to establish requirements for the implementation, maintenance and assessment of a quality management system for the production of medical devices;

– to establish a requirement to reissue licenses for the technical maintenance of medical device manufacturers by 31 December 2022;

– to grant the possibility of circulation of medical devices according to technical documentation in cases when registration certificate is expired and after 180 days in case of amendment of the registration certificate.

At the end of April 2021, the document was approved by the Russian parliament and signed by the President, although it has not yet come into force.

2. Discussions on the Simplification of Registration for Russian Manufacturers

Another initiative that was discussed and proposed by the Russian government over the last month was draft regulations (link in Russian), suggesting the simplification of the national registration process (an accelerated one-step registration) for Russian manufacturers. This would be on the condition that performance type testing, overseen by Russian healthcare regulator Roszdravnadzor, is carried out in the testing lab of the expert body.

The same draft proposed the possibility of two additional request/deficiency letters from Roszdravnadzor during the national Russian registration procedure (instead of one request as it stands currently) to minimise the possibility of registration rejections.
By the end of April 2021, the document had reached public discussion.

3. Development of Regulations on Remote Quality Management Audits for Medical Device Manufacturers

On 30 April 2021, the Eurasian Commission published a draft document (link in Russian) on the amendment of the Eurasian Requirements for Quality Management Systems for Manufacturers of Medical Devices (which were previously implemented in the Eurasian Regulation #106).

According to the proposed amendments in the draft document, the quality management audit (required for Eurasian approval of medical devices classed as high risk) may be performed in remote mode with approval from the regulator and on the condition that there will be a standard audit within two years of the virtual inspection.

The draft document is expected to be in public discussion until the end of May 2021.

Earlier in April 2021, the Russian Agency on Technical Regulating and Metrology released the national standard GOST 59424-2021 with guidelines for performing remote analysis of the management system.

The QMS audit is a mandatory step for the approval process of IIb and III class devices, according to Eurasian regulations. Due to travel restrictions caused by the pandemic and a lack of clear guidance, however, switching to Eurasian approvals remains highly uncertain for manufacturers. 

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