The Ministry of Health has approved an updated procedure for conducting technical, toxicological, and clinical trials required for the registration of medical devices. The previously applicable regulation (Order No. 885n) will cease to be effective September 1, 2026.
Main innovations
– Shortening and tightening deadlines. Application review is now scheduled within 10 business days, and testing is scheduled within 30 business days, with the possibility of a single extension of no more than 20 days.
– Conversion to electronic format. Results may only be recorded digitally using an enhanced qualified electronic signature (QES). All data must be entered into the Roszdravnadzor information system.
– Benefits for in vitro diagnostics. Reagents, calibrators, and culture media are exempt from mandatory technical testing.
– A special regime for software with artificial intelligence. Such products require the generation of test data samples and an assessment of clinical validity.
– Clear grounds for clinical trials involving humans. Conducting “live” trials becomes mandatory for new types of products, those using complex technologies, those with expanded stated indications, and those using new construction materials.
Transition period
Applications submitted before September 1, 2026 will be considered in the same manner as before.
Recommendations for manufacturers
– Check the current accreditation status of the testing laboratory.
– For AI-based solutions, prepare test datasets and collect supporting documentation.
– Assess whether the product meets the new criteria for mandatory clinical trials. – When planning your application, please take into account the transition period and possible changes in procedures.
