Implementation Update

Implementation has been delayed by 1 year to January 1, 2023. Manufacturers are able to still submit under Russia’s national regulations until May/June 2022. 

Regulations are Currently Expected to Take Effect at the End of the Year

With the release of Decree 142, the Russian government has provided a roadmap for their transition to the new EAEU medical device regulations beginning January 1, 2022. After this date, all applications submitted must adhere to the EAEU rules which can vary significantly from the current Russian requirements. To date, only 4 medical devices have been registered under EAEU rules even though 5 countries (Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia) are members. Manufacturers wishing to submit under the current Russian regulations need to expedite their applications to meet the January 1, 2022 deadline. While some might consider the delay as a sign that the implementation will be delayed, manufacturers should be cautioned Russia’s Roszdravnadzor, or RZN, have swiftly implemented new regulations before.

Seeking Registration in 2021

At this time, due to the uncertainty surrounding the actual implementation date, some manufacturers may need to enter a holding pattern for the next couple of months until more information is announced. If implemented as planned, all Russia applications submitted before December 31, 2021, will be accepted under the current regulations and granted a 5-year validity. However, if manufacturers cannot submit before the end of the year and the implementation date isn’t postponed, much of the work completed won’t be compatible under the new EAEU regulations. Therefore, manufacturers of high-risk devices may not want to begin applications until further guidance is provided. Low risk devices, on the other hand, may still be able to submit their applications before the potential deadline as application compilation and testing time is significantly reduced.

How the EAEU Regulations are Different

The EAEU regulations are set to expand QMS and clinical trial requirements for international manufacturers. Class IIa sterile, Class IIb, or Class 3 will now need to have an onsite inspection rather than using a legalized ISO 13485 certificate, as was allowed under previous Russian requirements. Additionally, the EAEU regulations will now require international manufacturers conducting multi-center trials to have one of their sites in an EEU member country in order to be registered. Previously, manufacturers could avoid clinical trials by demonstrating evidence of a predicate product already approved and on the market.

Transition Details

According to EAEU regulations, registration certificates issued according to national registration procedures of member states will be valid until terms of their validity in accordance with the national rules. Originally, under Decree 1416, Russian registration certificates were originally expected to be grandfathered into the new system and never expire. However, additional guidance has been released stating that all registrations, including those approved by Russia, will need to register under the new system by December 31, 2026. To date, only 5 products have been approved under the EAEU regulations and listed on the public database. Four of the devices are manufactured by Russian companies while the fifth is from Belarus.

Grow With Us

Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in Russia.

Contact Asia Actual for a free consultation to discuss how these changes may affect your business.