Medical Device Registration in Russia

First Stage of Dossier Preparation

Second Stage of Dossier Preparation

The timeframe for obtaining registration certificates for medical devices

The duration for preparing a registration dossier depends on the risk class of the medical device (MD), the chosen registration scheme for the MD, the required volume of testing, and the extent of documentation that needs to be prepared. We register devices within very tight deadlines, as we conduct certain stages of the procedure in parallel where possible, saving your time. The expedited preparation of the registration dossier can take as little as 1.5 months with prompt provision of all required documentation, information, and samples. The average time for preparing the registration dossier is 3-4 months.

The review period for the registration dossier by the ROSZDRAVNADZOR:

Documents for Medical Device Registration

To assemble a registration dossier (a set of documents required for the registration of a medical device), the following documents are needed:

For domestically produced devices:

• Taxpayer Identification Number (INN), Primary State Registration Number (OGRN), and an extract from the Unified State Register of Legal Entities (EGRUL);
• Notarized power of attorney authorizing representation on behalf of the applicant;
• Quality Management System (QMS) compliance certificate, if available;
• Documents proving the existence of a manufacturing facility;
• Technical Specifications (TS), if available (we can develop this document if it’s absent);
• Description of the device to be registered;
• List of devices that need registration;
• Operational documentation, if available (we can develop this document if it’s absent);
• Act of qualification tests, if available;
• Photographs of the device to be registered (we can take these if samples are provided);
• Samples of the medical device (the required quantity of samples is determined based on the types and volume of the required tests).

For foreign-manufactured devices:

• Document registering the manufacturer as a legal entity in the country of manufacture;
• ISO 13485, ISO 9001 certificates, audit report, if available;
• Power of attorney for the manufacturer’s authorized representative in the Russian Federation;
• Documents confirming manufacturing conditions (e.g., business license);
• Technical file, if available (we can develop this document if it’s absent);
• Operational documentation, if available (we can develop this document if it’s absent);
• Photographs of the device to be registered (we can take these if samples are provided);
• Samples of the medical device (the required quantity of samples is determined based on the types and volume of the required tests);
• Reports of conducted tests (test reports);
• Risk management file;
• Reports on medical device validation and verification (reports on packaging stability, software verification, etc. These are requested depending on the requirements for the particular type of MD and are formed during the analysis process);

Depending on the complexity of the medical device, its risk class, and functional characteristics, the list of required documents may change.

Upon a positive outcome, the federal service issues a registration certificate and its annex.

We provide management and professional assistance at all stages of the project, including dossier preparation, addressing remarks, and preparing substantiated responses to expert services inquiries.

Please send us your inquiry. Our registration specialists will analyze your data, select an optimal registration algorithm, evaluate the volume of work required for dossier preparation, and send you a commercial offer for these services.