By order of Roszdravnadzor, administrative regulations were introduced for the provision of extracts from the state register of medical devices and organizations (IE) engaged in their production and manufacture.
The regulation is valid until 1 March 2028.
Main parameters of service provision
Applicants : legal entities, sole proprietors, and individuals. Applications may be submitted through a representative with a power of attorney.
· Statement form : exclusively electronic.
· Deadline : 5 working days from the date of registration of the application and a complete set of documents.
· Methods of submission:
- The original application and a copy of the power of attorney – by mail;
- An electronic version of the application and power of attorney can be submitted through the Unified Portal of State Services (UPGS) and signed with an enhanced qualified or unqualified electronic signature.
Reasons for refusal: an exhaustive list. The Regulations clearly limit the cases in which an extract will not be issued. Suspension of the service is not provided for, and refusal may be made solely for formal reasons:
· incomplete information in the application or inability to read the text;
· failure to submit an application and power of attorney (when a representative applies);
· submission of documents by an unauthorized person;
· non-compliance of the request with the rules for maintaining the state register;
· absence of an electronic signature if documents are sent through the Unified State Services Portal.
It is important that the service is not subject to a fee, and if the package of documents is complete and correct, the application will not be refused.
Market implications
The regulation completes the legal framework for the electronic register of medical devices, launched on March 1, 2022 (RF Government Resolution No. 1851 of October 28, 2021).
Global context: why the order expires on March 1, 2028
The time limit is no coincidence. Within the Eurasian Economic Union, a systematic transition to unified medical device markets is underway. The transition period for the introduction of common registration rules and a unified registry ends on December 31, 2027. It’s highly likely that the national regulation is deliberately timed: by March 1, 2028, the issuance of extracts from the national registry may be replaced (or harmonized) with the Eurasian mechanism. Thus, the current document acts as a “bridge,” ensuring procedural transparency for the remainder of the Russian registration system.
