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

1.Draft Protocol on Prolongation of the Eurasian Transition Period until 2025

On 19 August 2022, the Council of the Eurasian Commission announced (link in Russian) approval of the protocol of amendments to the Eurasian Agreement on common principles and rules of circulation of medical devices and prolongation until 31 December 2025 of the transition period with possibility of registration of medical devices according to the national regulations.
According to the announcement on the website the Eurasian commission, the draft protocol with abovementioned amendments was forwarded to the Eurasian member states for carrying out procedures necessary for signing and implementation of this regulation.
The Eurasian Agreement on common principles and rules of circulation of medical devices was enforced by the Eurasian Commission in 2016; the transition period, that was initially established as 31 December 2021, was already extended for one year in June 2022.

2.Simplification of the Procedure of Importation of Samples of Medical Devices for Registration

On 8 August 2022, the Russian medical device regulator Roszdravnadzor has announced (link in Russian) change of the procedure of importation of samples of medical devices for registration in Russia. 
Since that date the requirement to obtain the sample importation permit for registration was cancelled and replaced by new requirement to submit online notification with information on imported samples. 

3.Enforcement of the Requirement on QMS Inspections for National Registration Procedure

On 1 September 2022, the regulation #135 (link in Russian) is coming into force. This document is establishing rules for the inspection of quality management systems (QMS) for medical device manufacturers and introduces mandatory requirements to perform QMS inspection and submit QMS inspection reports for national Russian registration and amendment procedures for IIA sterile, IIB and III class medical devices.

The regulation established nine months (i.e. until 1 June 2023) transition period. Within this timeline, registration and amendment procedures may be done with submission of ISO 13485 inspection report on condition that postponed inspection to be performed by the Russian component authority within 2 years after approval.

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