- Which document regulates the registration procedure?
Decree No. 1416 of 27 December 2012 on the Adoption of the Rules for the State Registration of Medical Devices.
- Who may apply for the registration of a medical device in Russia?
The applicant for registration may be the developer of the device, the manufacturer or a person (organisation) authorised by the manufacturer.
- Which state body is responsible for registering medical devices in Russia?
Federal Healthcare Supervision Service (Roszdravnadzor).
The applicant must submit the application form together with the relevant documents to Roszdravnadzor.
- Which documents are required for registering a medical device in Russia?
1. registration application form (provided on the official site of Roszdravnadzor)
2. copy of the document authorising the manufacturer's representative;
3. information on the regulatory documentation for the device (i.e. documents containing requirements pertaining to the safety, quality and effectiveness of the device as well as methods of testing for compliance with these requirements);
4. technical documentation of the manufacturer for the device (i.e. documents regulating the construction and design of the device which set technical requirements and contain information for the development, manufacture, use, operation service, repair, utilisation or disposal of the device);
5. operation documentation, including user instructions or operation manuals;
6. photographic image of the device and any items necessary for the use of the device (at least 18x24 cm).
7. documents containing the results of technical tests and assessments of the device;
8. documents containing the results of toxicological assessment of the device, if the use of the device involves contact with human body;
9. documents containing the results of assessments in order to determine the type of a measurement device (for devices which are measurement devices subject to the state supervision);
10. list of attached documents;
11. information and documents confirming clinical effectiveness and safety of the medical device (if available);
12. draft clinical test plan together with grounding materials (if available).
All documents must either be in Russian language or be certified translations (e.g. translations certified by a notary).