Certification of medical devices

This text has been translated using machine translation tools.

Products approved by Decree of the Government of the Russian Federation dated December 1, 2009 N 982 (as amended on September 26, 2016) are subject to mandatory certification.

A certificate of conformity confirming the quality of the product, its compliance with the safety requirements of various standards and regulations, is issued for mass production, a one-time batch of goods, as well as for a supply contract.

Depending on the purposes of certification, the set of documents required to obtain a certificate of conformity may vary.

Certification of medical devices, and in particular certification of medical equipment and equipment, is a guarantor of the quality and safety of medical devices.

According to GOST, medical products are devices, instruments, dressings, reagents, dental materials, medical kits, software, as well as metal, plastic, rubber and glass products used in medicine.

Documents that must be submitted for certification of medical devices:

The applicant must submit the following documents to the medical device certification center:

• copy of the Charter;
• certificate of state registration of the enterprise;
• certificate of assignment of an identification number to the enterprise;
• documents confirming the ownership of the person submitting the application to the production areas;
• technical plan documentation, which contains a description of production and information about the products being manufactured;
• clinical trial protocol.

Quality certificates can be issued by both product manufacturers and suppliers. The manufacturer can immediately issue documents to its official representative if desired. However, if the manufacturer issues a certificate for himself, this makes it possible to work directly with customers without involving a distributor.