Registration of medical devices is a process that includes assessment and confirmation of safety, effectiveness and quality of medical devices before they are launched to the market. Registration is necessary to ensure protection of public health. Since March 1, 2025, registration of medical devices is regulated by the Decree of the Government of the Russian Federation as of November 30, 2024 No. 1684.
What documents are required to register a medical device?
When registering medical devices that do not require clinical investigations with human subjects in accordance with the Decree of the Government of the Russian Federation No. 1684, the applicant needs to prepare the following list of documents using their personal account:
- Application.
- Information on the results of clinical investigations without human subjects.
- Copies of documents confirming the powers of the authorized representative of the manufacturer.
- Information on regulatory documentation.
- Technical documentation.
- Operational documentation.
- Color photographs (at least 18 x 24 cm in size), including markings and packaging, as well as, if available, color images of the electronic media and software interface.
- Draft description and verification methodology for the type of measuring tools.
- Documents confirming the results of clinical investigations (as applicable).
- Documents confirming the possibility of using the specified address (or addresses) as a production site (as applicable).
- Documents confirming the manufacturer’s right to use the trademark and other visual identity means of a medical device, if they are applied to its packaging (if the information is not registered in the relevant registers of the Federal Service for Intellectual Property).
- Copies of documents confirming the quality of the matter or other matter, that is a part of the medical device or that was used to manufacture it (except for in vitro devices).
- Copy of the document confirming registration of the manufacturer as a legal entity or individual entrepreneur (except for medical devices manufactured by residents of the Russian Federation);
- Clinical monitoring program (as applicable);
- Evidence from the manufacturer (vendor) of the medical device (as applicable).
Terms of state registration of a medical device
Completeness and accuracy of the submitted documentation and the information thereof are checked within 5 business days after receipt of the application and the documents of a registration dossier.
If the registration dossier is drawn up with violations, is not submitted in full, or contains inaccurate information, Roszdravnadzor notifies the applicant that the identified violation should be corrected within 30 business days.
If the documents are submitted in full and contain reliable information, or if the identified violations are corrected within 30 business days, then within 3 business days Roszdravnadzor concludes to start registration of the medical device.
If the applicant has not provided the missing documents or has not corrected the identified violations within the time limit, Roszdravnadzor sends a notification to the applicant in electronic form about termination of further consideration of the registration dossier with a justification of the reasons.
Registration of a medical device that does not require clinical investigations for human subjects is carried out within 31 business days from the date of the actual start of registration.
Assistance in registering medical devices
Registration procedure of a medical device is a complex and multi-stage process that requires a significant amount of knowledge and experience. That is the reason why we recommend you contacting specialists with extensive, long-term experience in this field.