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

  1. New Revision of the Eurasian Medical Device Registration Rules

On 18 July 2022, the Decision of the Eurasian Commission #144 (link in Russian) came into force, implementing several significant changes in the current Eurasian medical device registration rules:

  • Updated criteria for grouping of products in one application for registration not linked with nomenclature code (see clause 19);
  • Clarified requirement to have at least one Eurasian acceptance state  in addition to reference state for registration application (see clause 16 and 21);
  • Updated requirement on list of administrative documents (e.g. mandatory contract between Manufacturer and Eurasian authorized representative – see Annex IV clause 3);
  • Updated terminology: “components”, “consumables” have been replaced with terms “composition” and “accessories”;
  • Updated requirement on QMS inspection for sterile 2a, 2b and 3 class devices henceforward may be done within 45 days after start of expert review after possible deficiencies of expert body are resolved but not before the submission (see clause 26);
  • Introduced a possibility for certain amendments in registration licenses to be done as notification without review of the competent authority (see chapter VI);
  • Some other changes.

For the end of July 2022, there are 10 medical devices registered according to the Eurasian regulations.

2. Discussions on Further Prolongations of the National Registration Procedures in Russia

 In June 2022, the Eurasian commission confirmed a prolongation of the transition period from the national to Eurasian medical dveice regulatory system and re-opened submissions on medical device registration according to the national requirements until the 31 December 2022.

In July 2022, the Russian Ministry of Health, in the response to the request from the manufacturers and distributors, admitted a possibility of the further extension of the national procedure for registering medical devices until the end of 2023.

According to the response of the Regulator, this initiative is currently being discussed internally, and the draft protocol with possible amendments will be considered by the Eurasian member states at the next meeting of the Council of the Eurasian Economic Commission.

3. Simplified Registration for Eurasian Manufacturers in Belarus

On 9 June 2022, the Belorussian Ministry of Health released the regulation #52 (link in Russian)
which provided an opportunity for medical devices manufacturers located within the Eurasian Union and having their products approved in USA and European union to pass simplified registration process in Belarus (i.e. without hygiene tests, clinical trials, and production inspections).

The same regulation introduced a new supplemented sub-clause (see 5.2.4) regarding regulation of research-use only (RUO) products in Belarus.