Russia – Decision on rules of registration and of the safety, quality, and efficiency inspection of medical devices

Eurasian Economic Commission has issued notification on draft decision of The Board of the Eurasian Economic Union "On the rules of registration and of the safety, quality, and efficiency inspection of medical devices"

This draft decision establish procedures of registration and evaluation of safety, quality, and efficiency of medical devices, of the procedures of modification the registration dossiers of a medical device, of the issue of registration certificate duplicates, and of the procedures of denial of registration, suspension and repeal of registration certificate for medical device.

Proposed date of adoption: 5 July 2016

Proposed date of entry into force: 1 January 2017

Final date for comments: 5 June 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.