Russia

Legislation

Russian Market (GOST)

Before placing a medical device on the Russian market, it is necessary to obtain a series of product approvals to ensure the safety for the user or the patient.

The mandatory approvals are three and require a long and tortuous process and they are as follows:

- Registration with MINZDRAV (Ministry of Health and Social Development)

- GOST-R Certification

- Certification of hygiene and sanitation at Rospotrebnadsor

Given the complexity of the approval it is fundamental to have a representative on Russian territory acting as an interface between the Bodies and Authorities.

ISEMED proposes, with its partners on the Russian territory, to carry through the approval process by the Russian Authorities which issue the necessary certifications.