This text has been translated using machine translation tools.
According to the Decree of the Government of the Russian Federation dated December 1, 2009 N 982 “On approval of a unified list of products subject to mandatory certification and a unified list of products, confirmation of conformity of which is carried out in the form of a declaration of conformity,” medical devices are subject to mandatory declaration of conformity in the GOST system and mandatory certification.
For legal use in healthcare of the Russian Federation, all medical products must be registered in the State Register of Medical Devices, which is maintained by the authorized government body - Roszdravnadzor. Medical products must have a Declaration of Conformity in accordance with the list of mandatory declarations according to GOST R.
A declaration of conformity for medical devices is issued only for products defined at the legislative level; voluntary registration of the declaration is impossible. The applicant, and not the certification body, is responsible for the completeness and accuracy of this information. The declaration is valid only within the Russian Federation.
The legislation establishes mandatory declaration in the GOST R system for such groups of medical goods as:
