a draft order for public discussion approving a new Procedure for Organizing and Conducting Evaluation of the Quality, Efficacy, and Safety of Medical Devices. The document repeals the current Order No. 206n of March 20, 2020 (as amended by Order No. 386n of April 22, 2021), comes into effect on March 1, 2027, and remains in effect until December 31, 2028.
What’s changing?
1. Complete update of the procedure: Order No. 206n ceases to be in effect (it is currently applicable until September 1, 2027), and an independent procedure is introduced in its place.
2. Formation of a new regulatory chain: the new procedure will work in conjunction with updated regulations: the procedure for conducting technical, toxicological, and clinical trials was already adopted in 2026 (Order No. 421n, effective September 1, 2026). A unified logic is being established: trials → registration dossier → expert review → registration → post-registration monitoring.
3. Strengthening the role of the dossier content: it is important for the manufacturer not only to correctly complete the application, but also to justify in advance the relationship between the changes, product characteristics, test results, and confirmation of safety and efficacy.
4. Special focus on complex products and software: Software as a medical device, including AI-enabled solutions, has already been identified as a separate category. For digital product manufacturers, a regulatory strategy is becoming no less important than preparing a technical dossier.
5. New transition period: For companies with registration projects scheduled for 2027–2028, the key question is what procedure will apply to existing assessments and applications submitted before the order comes into force.
Advantages
– Updating the procedure taking into account market and technological developments.
– Systematic linkage of testing, registration and post-registration control.
– A contemporary approach to modern products, including digital ones.
Risks
– Possible regulatory uncertainty during the transition period.
– Increased burden on preparing and maintaining dossiers.
– The need for careful assessment of the regulatory implications of product changes.
– For software and products with AI, there is a need for constant change control.
Terms and basis
– Entry into force – March 1, 2027.
– Valid until December 31, 2028.
– Legal basis: Part 8 of Article 38 of Federal Law No. 323-FZ of November 21, 2011.
