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

  1. Re-opening of medical device registration submissions according to the national requirements

In January 2022, the Russian medical device regulator Roszdravnadzor, as well as regulators of other Eurasian member states, announced the closure of submissions for medical device registration files complying with the original national regulations due to the end of the transition period established by the Eurasian Agreement on common principles of circulation of medical devices.

However, since December 2021 there were active discussion on potential prolongation for another year.

Thus, finally, in June 2022, the Eurasian commission confirmed a prolongation of the transition period and re-opened submissions on medical device registration according to the national requirements until the 31 December 2022.

For the end of June, submissions are open in Russian, Kazak and Belorussian medical device regulators.

Meanwhile, according to the Eurasian database there is information about 8 medical devices approved and more than 50 dossiers submitted for registration according to new Eurasian requirements.

2. Simplified Registration Process for medical devices in risk of shortage

On 1 April 2022, the Russian government released the resolution #552 (link in Russian) and introduced several new, simplified and accelerated paths for registration of medical devices included in the special list in order to deal with a potential shortage of medical devices as a response to economic sanctions.

In June 2022, Roszdravnadzor published two editions of the list, which includes more than 1500 nomenclature codes of medical devices.

According to the new procedure, registration of non-sterile class I medical devices included in the list(s) may be done within five days based on the assessment of administrative documents, in condition of performing the testing  within 50 days and submission of other documents within 150 days after approval;

Registration of medical devices of all classes included in the list(s) may be done based on shortened review and simplified of certain requirements for clinical trials and product testing.

According to the resolution #552, the simplified registration procedures will be open and registration certificates issued according to this process will be valid until 1 September 2023.

3.Update of the Eurasian Technical Regulation on Electromagnetic Compatibility

On 10 June 2022, the Eurasian Economic Commission published a Decision # 91 (link in Russian) and excluded medical devices from the scope of the technical regulation of the Customs Union on TR 020/2011 on the electromagnetic compatibility of technical devices. Over the last years, certification to this regulation was often requested by Customs authorities of Eurasian member states in addition to medical device registration.