Новости

Medical devices declaration cancellation in Russia since January 1, 2021

As part of the Russian legislation revision and in order for the regulatory burden relaxation, the mandatory Declarations of Conformity for medical devices were canceled since January 1, 2021. The cause of the cancellation is based on the Russian Federation Government Decree dated July 4, 2020, No. 982.



Thus, obtaining the Declarations of Conformity for medical devices from accredited certification centres is not indispensable, and it can be skipped.


This news is especially great for manufacturers and distributors of medical devices because they now do not have to spend additional funds for obtaining any declarations of conformity. Moreover, any amends in declarations had been impossible before it was cancelled and having some changes in the information specified in the declarations you had to obtain new declarations each time. So, the cancellation has lots of advantages.