After receiving the Certificate of Registration, mandatory certification of medical equipment in an accredited certification body follows in the form of a GOST R declaration of conformity or certification. The application and the required certification documents are submitted. Documents submitted are subject to examination. If the result of the examination is satisfactory, then the applicant is issued a declaration of conformity.

The following documents are required for registration of the declaration or certificate:

•  Application

•  Product Test Reports

•  QMS certificates, quality declarations, raw materials certificates (if available)

• TIN Certificate

• OGRN certificate

• Charter

• For imported products – shipping documents

The concept of medical devices covers a wide range of products – from equipment, consumables to medical furniture. Products for medical purposes are divided into classes according to the degree of risk and function – the source of energy, the way of interaction with the human body, etc. For their legal use in medical institutions of the Russian Federation and Customs Union, all medical devices must pass the registration in the Federal Service for Surveillance in Healthcare register.

How to get a medical registration certificate and what to do next?

To register a medical product, you must: apply for registration, provide samples of medical equipment and the necessary documents.

A list of the key documents from the manufacturer:

• ISO 13485, with Apostille

• ISO 9001, with Apostille

• CE / 93/42 from the certification body, with Apostille

• Extract from the Chamber of Commerce of manufacturer, with Apostille

• Power of attorney for the authorized representative, with Apostille

• Free sale Certificate (if available), with Apostille

• A document confirming the fact of registration of products in the country of origin (if available), with Apostille

• Risk analysis of production, assures by manufacturer

• Data validation of the sterilization process, if the product is subjected to sterilization, assures by manufacturer

• Information about the sterilization process, method, method parameters

• Test report on the claimed products held in the country of the manufacturer, assures by manufacturer

• Clinical studies carried out on the territory of the country of origin, or a program of clinical trials, assures by manufacturer

• Information on the use of standards (DIN, ISO, JIS, EN, BS EN, etc.) in the country of origin, in the form «number and title» of the standard, assures by manufacturer

• Technical file the STED DHTF form, assures by manufacturer (For processing to send in electronic form)

• User’s manual

• Instructions for use for the market of the Russian Federation, assures by manufacturer.

A list of the key documents from the authorized representative in the Russian Federation:

• Layout of marking for the market of the EAC, certified by an authorized representative of the manufacturer

• Layout of packaging for the market of the EAC, certified by an authorized representative of the manufacturer

• Application for registration (must specify exactly which model it is necessary to register), certified by an authorized representative of the manufacturer

• The application for the import, certified by an authorized representative of the manufacturer

• Label, certified by an authorized representative of the manufacturer

• Pictures of the products certified by an authorized representative of the manufacturer

• Extract from EGRUL

• The certificate of registration (a notarized copy)

• Samples for the technical, toxicological, clinical trials.