Comprehensive Overhaul of Russian Pre-Registration Testing
On May 13, 2026, the Ministry of Health of the Russian Federation (Minzdrav) approved Order No. 421n, establishing an updated regulatory procedure for evaluating medical device conformity through technical testing, toxicological studies, and clinical trials for national state registration. Registered by the Ministry of Justice on June 1, 2026 (Registration No. 86767, Publication No. 0001202606010040), the order officially took effect on September 1, 2026, and remains valid through September 1, 2032.
Order No. 421n directly repeals and replaces the previous framework under Order No. 885n of August 30, 2021. Operating as a fundamental technical annex to the national registration framework under Government Decree No. 1416, the new order updates pre-market evidentiary requirements, clarifies testing workflows for digital health technologies, and establishes formal electronic document integration.
Key Regulatory Revisions and Testing Protocols
The new order introduces several operational shifts for domestic and foreign device manufacturers:
- Specific mandates for medical software and artificial intelligence: For software as a medical device (SaMD) and equipment integrating AI algorithms, manufacturers must supply testing institutions with not only technical documentation, but also direct access to functional software builds, benchmark test databases (datasets), and authorized testing environments to assess algorithmic reliability and analytical accuracy.
- Consolidation into standardized protocols: Test documentation formats have been streamlined. Technical testing and toxicological evaluations now formally culminate in standardized “Protocols” rather than fragmented acts or hybrid expert conclusions. The order formally authorizes electronic document management (EDO) utilizing certified digital signatures throughout the evaluation lifecycle.
- Criteria for clinical trials with human subjects: The regulation refines the mandatory criteria under which full-scale clinical trials involving human participants are required in Russia. Human subject trials are mandatory when device design changes directly impact primary clinical function, when intended clinical indications are expanded, or when equivalence cannot be substantiated through bench data and scientific literature.
- Targeted testing exemptions for IVD consumables: Explicit exemptions from bench technical testing are codified for specific in vitro diagnostic consumables—including certain chemical reagents, control sera, calibrators, and nutrient culture media—where physical bench testing is non-applicable.
- Institutional review deadlines: Testing and medical organizations face defined timelines: institutions must review application dossiers within 10 working days and officially notify the applicant within 3 working days regarding whether they possess the accreditation and capacity to execute the requested testing.
Practical Checks for Manufacturers
Companies registering or modifying medical devices under the Russian national registration system should verify the following points:
- Align test reporting with 421n protocol templates: Ensure Russian authorized representatives and accredited local testing laboratories issue test reports following the standardized 421n protocol format for studies initiated on or after September 1, 2026.
- Prepare independent validation environments for AI/SaMD: For connected medical devices, digital platforms, and AI-enabled algorithms, assemble representative test datasets and establish secure access environments for Russian testing centers.
- Screen registration dossiers for human clinical trial triggers: Audit planned submissions and major design variations against the updated human trial criteria to confirm whether clinical data from literature reviews remains acceptable or whether domestic clinical trial approvals must be budgeted.
Sources
- Primary official sourceOrder of the Ministry of Health of the Russian Federation No. 421n (opens in a new tab)Ministry of Health of the Russian Federation