Here is my traditional end-of-year review of the key updates in Russian and Eurasian medical device regulation over the last year and expected changes in the nearest future, as well as short overview of medical devices approval routes which are currently valid in Russia.

Regular registration procedure

The national registration procedure according to the regulation #1416 is remaining the principal and most common approval route for major part of new medical devices coming into the Russian market.

On 13 February 2023, the national medical device registration procedure has been officially prolonged, while full transition into the Eurasian medical device regulation model, that was previously planned for 31 December 2022, has been postponed until 31 December 2025. That means that until this deadline, medical device registration submissions in Russia may be prepared according either to the national or to  Eurasian medical device registration rules.

• The most important update for the national medical device regulation for today is coming into force, since 1 January 2024, of the requirement of mandatory Quality Management System (QMS)  inspections  before submission for new registration and most of registration amendments for  IIA sterile, IIB and III class medical devices.
  
  Since 2022, these inspections were  the Russian government have been published and updated several revisions of key documents on this upcoming requirement:  the regulation #135 on rules for conducting QMS inspection for medical device manufacturers and regulation #136 “on approval of requirements for implementation, maintenance and assessment of QMS depending on risk classification” and QMS inspections were voluntary for national registration.
  
  At the end of December 2023, we can find more than 20 records on completed QMS inspections in the national database of the Russian medical device regulator Roszdravnadzor.

• Another important change expected in 2024 is entry into force of the new national registration procedure according to the draft that was published and updated since April 2023.
  
  The new revision of the registration rules contains multiple updates, and overall make national registration process more harmonized with Eurasian medical device registration requirements.
  
  Among other proposed changes, the draft regulation is introducing separate registration procedure for domestic medical devices and simplified registration for certain group of low class medical devices, in-vitro diagnostics and IT-products including artificial intelligence. According to the draft document, the new procedure will allow electronic application and provide additional materials using electronic submissions.
  
  
• It should be also mentioned, that on 1 September 2023, the Russian Ministry of Health introduced updated procedure of importation of samples of medical devices for national registration.
  
  Simplified pathways

In parallel with abovementioned “regular” registration process, for the end of 2023, there are also several simplified pathways to approval for medical devices and in-vitro diagnostics:

• “Fast track” national route for approvals according to the regulation #552 for medical devices in risk of shortage. This procedure was introduced on April 2022 as a response to restrictive economic measures against the Russian Federation and implies simplified administrative requirements and expedited timelines for review for temporary registration (until 1 January 2025) for the medical devices listed in the regulation. The last revision of this list was published by Russian medical device regulator Rosazdravnadzor in August 2023 and contains more than 1900 types of medical devices.  

At February 2023, the regulator says about 31 medical devices approved under this procedure in 2022. 

• Over the last year, there were no significant updates for another simplified registration route according to the regulation 299 which is applicable since March 2020 for 36 types of class I medical devices and protective equipment. The official timeline for registration review for these products are significantly shorter (up to five business days) on the condition that the manufacturer provides reports on type-testing and clinical assessment performed in Russia within five months after the approval date. It is worth mentioning, that in case such reports are not provided within established timelines, the regulator may withdraw such type of registration.
• There were no major updates in the procedure of temporary registrations of particular batches of certain medical devices and in-vitro diagnostics intended for use in conditions of military and emergency situations according to the regulation #430 that was enforced in April 2020 as response to COVID-19 pandemic and afterward prolonged until 1 January 2025. Roszdravnavnadzor says about 158 medical devices registered over 2022.
• At April 2023, the Russian medical device regulator announced first approval according to the new route intended for certain in-vitro diagnostics. This procedure according to the regulation #2026 is effective since November 2021 and applicable for certain in-vitro diagnostics intended for use within the same organization where it was manufactured.

Eurasian Medical Device Registration

As mentioned before, the full transition from national into Eurasian medical device regulation model that was discussing since 2016 and previously planned for 31 December 2022, has been postponed until 31 December 2025.  For the end of December 2023, there are 35 medical devices approved according to the Eurasian procedure,  most of these medical devices manufactured within Eurasian countries. Over the last year, Eurasian economic commission continue to update existing Eurasian medical device regulations and released the following documents:

• On March 2023: the new revision of the Eurasian medical device registration rules and recommendation for organizations involved in QMS inspections for medical device manufacturers for registration according to Eurasian requirements;
• On May 2023: updated revision of the Eurasian medical device classification rules;
• On June 2023: recommendation #15 updated revision of the list of standards applicable for conformity assessment for medical devices;
• On November 2023: regulation #161 on amendment on rules of clinical trials for medical devices and in-vitro diagnostics in the Eurasian Economic Union.