Registration of medical devices
Registration of medical devices (MD) is a government-controlled process, which is necessary for confirmation of compliance of MD to norms and standards of Russian Federation.
Federal Law № 323 "Fundamentals of protection of health of in the Russian Federation" part 4, article 38, from 21.11.2011 specifies that only medical products, which are registered in the order defined by the Government of the Russian Federation and authorized federal executive authority, are allowed for market circulation in the territory of Russian Federation.
Registration process consists of several steps, according to the Statement of the Government of the Russian Federation № 1416 "Establishment of rules for registration of medical devices" from 27.12.2012.
Necessary documents for obtaining Registration Certificate for medical devices:
- Power of attorney with apostil, with notarized into Russian language
- Copy of an extract from the trade register with apostil, with notarized into Russian language
- Copy of ISO 13485 and/or ISO 9001 with apostil, with notarized into Russian language
- Copy of CE certificate with apostil, with notarized into Russian language
- Technical information on products (catalogues, passports, test protocols, operating manuals, risks analysis, list of implemented materials, etc.) in Russian language with a company stamp and a signature of responsible person / employee
- Sample units for tests
- Only a resident company, located in the Russian Federation, can apply for registration
- Period of validity of Registration Certificate: unlimited
- Timeframe of registration process: 12-16 months after the receipt of all required documents
- All documents must be in Russian language
Necessary information for primary estimation of project:
- Application area of MD
- Indications and contra-indications for use of MD
- Information on quantity and type of materials, which contact a patient directly or indirectly, while using of MD
- estimate class of risk of MD
- Information about analogues, which have been registered in the Russian Federation
Please, send us your request and our experts will check which certificates are required for the import of your goods to the territory of the Customs Union.
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