Roszdravnadzor Order No. 750, dated August 19, 2026, approved updated administrative regulations, replacing the 2019 document. These regulations define the service’s interactions with Russian and foreign manufacturers of medical devices, as well as their authorized representatives.
The essence of the changes
– A registry entry instead of a certificate. The procedure results in the entry of information into the state register of medical devices and manufacturing organizations. The issuance of a registration certificate or separate notification to the applicant is no longer provided.
– Seven service options – from registration with clinical trials to cancellation of registration.
– Software with artificial intelligence is now a separate category: an adjustment has been made to the documents for software with AI technologies recognized as a medical device (previously, this clause was absent).
Regulatory framework
When registering medical devices, the following should be taken into account:
– Decree of the Government of the Russian Federation No. 1684 of November 30, 2024 – establishes the rules for state registration;
– Order of Roszdravnadzor No. 750 dated August 19, 2026 establishes the administrative regulations for the provision of the service.
Terms of service provision
– With clinical trials – up to 50 working days;
– Without clinical trials – 31 working days;
– Domestic products – up to 10 working days;
– Changes to the AI software dossier – up to 10 business days;
– Changes to the dossier with examination – 36 working days (previously 30);
– Changes to the dossier without examination – 18 working days (previously 15);
– Cancellation of registration – up to 7 working days.
Interdepartmental cooperation through SMEV
– Federal Tax Service – information from the Unified State Register of Legal Entities and the Unified State Register of Individual Entrepreneurs, data on branches and representative offices of foreign companies;
– Rosaccreditation – data from the register of accredited persons and research protocols;
– Federal Treasury – confirmation of payment of state duty through the State Information System of State and Municipal Payments.
This reduces the amount of information that the applicant must independently confirm.
Extended grounds for refusal
– Conclusion of an expert institution on the impossibility of conducting clinical trials;
– Negative results of quality, efficacy and safety assessment;
– Discrepancies between the efficacy data and the application or registration dossier identified during federal government control.
The new regulation is valid until December 31, 2028.
