Roszdravnadzor has announced and submitted for public discussion a draft administrative regulation detailing the procedure for state registration of medical devices. The document aims to streamline processes, increasing their predictability and reducing the administrative burden on manufacturers.
The key innovation is a significant reduction in the time required for procedures:
* 10 working days is the maximum period for registering Russian products that do not require clinical trials (CT).
* 50 working days is the established period for products requiring clinical trials.
* From 10 to 36 working days is the period for reviewing applications for amendments to the registration dossier (depending on the complexity and need for examination).
* Special attention to digital solutions: a separate, shortened deadline of 10 business days has been allocated for changes to software documentation, including those with artificial intelligence elements.
Other important aspects of the project:
* Transparency of procedures: the regulations clearly outline all stages of service provision, as well as a comprehensive list of grounds for possible refusal.
* Digital format: the service will be provided exclusively electronically through the Unified State Services Portal (Gosuslugi) and the Interdepartmental Electronic Interaction System (SIEI). Submission of documents through the MFC is not possible.
* State duty retention: the obligation to pay it remains, the amount will depend on the potential risk class of the product.
The new regulations expand on the provisions of the updated Registration Rules, effective March 1, 2025, and specify the simplifications they introduce:
* A one-step procedure for Russian products, subject to testing at VNIIIMT and clinical studies at accredited national medical research centers.
* Possibility of including several models (modifications) of a product in one registration certificate.
* Harmonization of requirements with the regulatory framework of the Eurasian Economic Union (EAEU).
This initiative represents a significant step toward de-bureaucratization and digitalization of the medical device industry. Clearly defined deadlines and procedures minimize uncertainty for manufacturers and can stimulate the faster market entry of new technologies, especially those produced domestically.
The draft document is available for public comment until January 27, 2026.
