RUSSIA: Face masks not declared as PPE are not subject to certification

The Russian standardisation authority Rosstandart has clarified that if a manufacturer or importer places on the Russian market any face masks they do not claim to be personal protective equipment or masks declared as a part of clothes or apparel – these types of face masks do not have to undergo mandatory conformity assessment procedure.

RUSSIA: Face masks. Types, standards and legal requirements


Certification of face masks in Russia

Face masks sold in the Russian Federation can be assigned to one of the following categories:

-Medical devices (medical products);

-Personal protective equipment; and

-Other face masks.

Medical face masks

Russia: Simplified registration procedure for low-risk medical devices

As of 19 March 2020, importers and manufacturers of low-risk medical devices will have to undergo a separate registration procedure for such devices.

The amendments to this effect were adopted by Decree No. 299 of 18 March 2020 that amended Decree No. 1416 of 27 December 2016.