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Roszdravnadzor Updates Administrative Regulations for Medical Device Registration! Full Adjustments to Applicant Qualifications, Certificate Format and Review Timelines

Time：2026-09-21 10:58:39

Roszdravnadzor, the Russian Federal Service for Surveillance in Healthcare, has officially approved the new administrative regulations for state registration of medical devices, issued under Order No.750 dated August 19, 2026. It replaces the previous Order No.3371 dated May 6, 2019. The new regulations will remain valid until December 31, 2028.

This revision covers core rules including eligible applicants, registration certification format, administrative timelines for various procedures, and grounds for application rejection. It has a direct impact on domestic and overseas medical device enterprises planning to enter the Russian market, especially manufacturers of AI medical software.

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https://pharmvestnik.ru/content/news/roszdravnadzor-obnovil-administrativnyi-reglament-po-registracii-medizdelii.html

一、Core Changes for Applicant Entities

The new regulations clearly state: medical device research and development institutions no longer qualify as independent applicants.

Only two types of entities are permitted to submit applications for state registration:：

The medical device manufacturer itself;
The manufacturer’s authorized representative located within the Russian Federation.

Reminder: For overseas enterprises exporting medical devices to Russia, a legally compliant Russian authorized representative must be appointed to handle all registration-related formalities. R&D institutions cannot directly submit registration dossiers to the regulatory authority.

Meanwhile, there is a major change in registration evidence: the regulator will no longer issue standalone paper registration certificates. The only official proof of successful registration is the entry recorded in the State Register of Medical Devices. Enterprises may retrieve register entries directly as compliance documents for market circulation.

二、Adjustments to Timelines for Various Services

The new administrative regulations reset the official review timelines for different registration scenarios. Some procedures are accelerated, fast-track access is introduced for AI medical software, while lead times for certain services have been extended.

Service Type	New Timeline	Old Timeline	Description of Changes
Registration of medical devices without clinical trials	31 working days	35 working days	Reduced by 4 working days, streamlined process
Registration of domestically manufactured Russian medical devices	10 working days	—	Fast-track procedure
Registration of AI-based medical software	10 working days	—	AI medical software qualifies for the same fast-track pathway
Dossier amendments without expert evaluation	18 working days	15 working days	Extended by 3 working days
Dossier amendments requiring expert evaluation	36 working days	35 working days	Extended by 1 working day
Cancellation of medical device registration	7 working days	3 working days	More than doubled processing time

Note: The above periods refer to administrative review timelines of the regulator. They exclude external activities such as clinical trials, supplementary document submission by enterprises and laboratory testing.

三、Statutory Grounds for Registration Rejection Defined

The updated regulations add a formal list of grounds for rejection. Roszdravnadzor may directly dismiss registration applications under the following circumstances:

Conclusions indicate clinical trials cannot be performed or the product cannot complete registration;
Safety and efficacy data identified in the review are inconsistent or defective;
Registration dossiers cannot be revised to meet compliance requirements.

Enterprises shall fully verify complete safety and efficacy technical documentation before dossier submission to avoid direct rejection and delays to product launch.

四、Practical Guidance for Medical Device Enterprises Exporting Overseas

Sort out applicant entities in advance：Overseas manufacturers must confirm the validity of power-of-attorney documents for the Russian authorized representative. R&D institutes cannot act as registration submitters.

Update understanding of registration proof：Do not expect paper certificates. Successful registration is evidenced by State Register entries, which may be used for customs clearance, bidding and commercial distribution.

Benefit for AI medical software：AI medical software can apply the 10-working-day fast-track review pathway. Relevant manufacturers may schedule registration accordingly.

Longer lead time for amendments and cancellation：If dossier amendments or old registration cancellation are required, reserve extra processing time.

五、Closing Remarks

This version of administrative regulations will remain effective until the end of 2028. Roszdravnadzor will continue releasing implementing rules. Medical device exporters should closely monitor regulatory updates and keep registration dossiers and compliance documentation up to date.For further enquiries, please contact Wiselink Group.

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