- Russian national medical device regulatory system
Over the several years, a deadline for the end of the Russian national procedure of the registration was set as 1 January 2022. However, a few days before 2022, the Eurasian commission came up with a protocol for postpone the national registration deadline for another year, until 1 January 2023.
Due to the length of procedures of ratification and signing the protocol by all Eurasian Member states, the national registration procedure was closed during 6 months, and re-opened only in June 2022, when this prolongation came into force.
In August 2022, the Council of the Eurasian Commission announced approval of further prolongation of the Eurasian transition period with possibility of medical device registration submissions according to the national regulations until 31 December 2025.
This draft protocol has been circulated to the Member States and will come into force after ratification and signing. In November 2022, proposal on new prolongation was approved by the Russian government, but for end of December it is not yet been enforced officially.
- Updates in the registration procedure:
Over the year 2022, we me may see several updates in the national registration procedure:
-Since March 2022, a new regulations for pre-clinical and clinical testing for medical devices (link in Russian) have been enforced;
-Since August 2022, Russian medical device regulator Roszdravnadzor simplified the process of importation of samples for testing and registration (link in Russian);
-In September 2022, the Russian Ministry of health introduced a requirement of quality management system inspections for national registrations and renewal (re-registration) procedures of sterile IIa, all IIb and III class medical devices (link in Russian). This requirement was established with a transition period until 1 June 2023, until this date QMS inspection may be postponed for the next two years after registration approval. Since November 2022, the Russian Ministry of health is discussing extension of this deadline until 31 December 2023.
- Updates in post-market requirements:
It is worth mentioning two quite significant updates in the Russian post-market medical device regulation over the last year:
Since February 2022, according to the regulation #1113 (link in Russian), Manufacturers or their Russian authorized representatives are required to submit annual clinical post-market monitoring reports for class III medical devices and IIB implantable devices registered in Russia after January 2021;
Since March 2022, according to the regulation #11020 (link in Russian) for the purpose of safety monitoring of medical devices on the market, Manufacturers and Distributors have to inform Roszdravnadzor within 15 days, about every unit of any medical device imported into Russia;
- Other significant updates in the national medical device regulations:
Since September 2022, the Russian government released the regulation #2425 (link in Russian) and updated a lists of products subject to mandatory GOST certification and declaration. Current GOST certificates and declarations of conformity for products on the market, mentioned in the previous versions of the lists, will remain valid until 1 September 2025.
Medical and in-vitro devices intended for diagnostics and treatment of COVID-19 infection are still may be registered in Russia via simplified registration process until and receive approval until 1 January 2025. In the same time, part of these products already registered before, have been withdrawn from the market by the regulator.
2.Expedited registration process for medical devices in risk of shortage and other measures related to geopolitical situation
Since April 2022, the Russian government released several regulations “intended to improve the stability of the market for socially important goods and mitigate a risk of inventory shortage for medical devices caused by the economic restrictive measures imposed against Russia”.
The measures, among others, include “fast-track” medical device approval process for certain groups of medical devices and simplified re-registration procedure in case of change of the raw material and components for domestic medical device manufacturers;
The resolution #552 (link in Russian) enforced on 1 April 2022, introduced a possibility of the “fast track” registration for medical devices included the special list. Since April 2022, the list of devices, that has determined to be in shortage at this time, has been extended several times, and for the end of the year, it contains more than 1800 codes. Depending on classification of the device, (formal) timeline for fast-track review by the Regulator may start from five-business days while certain administrative and testing requirements for such submission are simplified. The registration approval for this procedure is granted for the limited period (initially established until 1 September 2023 and later prolonged until 1 January 2025). For the end of 2022, 18 medical devices have been approved according to this simplified process.
Among other measures, as a response to economic restrictive measures and complexity of the logistic process, the Russian regulators introduced ban for export from Russia of certain medical devices included in the special list, legalized a “parallel importing” in Russia for certain goods including medical devices without the permission of the trademark holder, introduced a requirement for manufacturers and importers of medical devices to notify the regulator prior to suspend or terminate business activity in Russia.
3. Updates in the Eurasian medical device regulatory system
Overall, we did not observe a major breakthrough in the development of the Eurasian medical device regulatory system over the last year.
For the end of the year 2022, there are 14 medical devices registered according to the Eurasian medical device registration system (versus 7 approvals in the beginning of the year), most of registered medical devices are manufactured by domestic Eurasian companies;
There are 22 testing laboratories and 41 medical organizations accredited for conducting testing and clinical trials of medical devices according to Eurasian requirements;
In July 2022, the Eurasian Commission released the Regulation # 144 (link in Russian) implementing new edition of Eurasian medical device registration rules with several updates in the procedure;
In August 2022, the Council of the Eurasian Commission announced approval of further extension, until 31 December 2025, of the Eurasian transition period medical devices registration submissions open both according to national and Eurasian regulations;
In December 2022, the Eurasian Commission announced approval of the roadmap for the further transition the common market of medical devices, which, according to the Commission, will ensure “unconditional transition” for registration of medical devices after end of transition period.