Duplicate of the registration certificate

Grounds for requesting a duplicate medical device registration certificate:

Adhering to the state registration rules for medical devices, as established by the Russian Federation Government Decree dated December 27, 2012, No. 1416 (clause 52); 

• If the registration certificate for a medical device is lost
• If the registration certificate for a medical device is damaged

The issuance of a duplicate registration certificate for a medical device takes 7 working days.

Documents and details needed for the duplicate registration certificate for a medical device:

• Application for the issuance of a duplicate registration certificate for a medical device by serial number;
• Payment of the state fee for the procedure of obtaining a duplicate of the registration certificate for a medical device, which is 2500 rubles;
• The worn-out registration certificate for a medical device (in case of replacement of a registration certificate for a medical device);
• The return of the registration certificate by the manufacturer of the medical device for the issuance of a duplicate is confirmed by a notarized translation into Russian;
• Letter from the manufacturer of the medical device with the reason for obtaining a duplicate registration certificate for a medical device;
• Notification of the previously issued power of attorney or the stated application for the first registration or for obtaining a duplicate registration certificate by the third person (in case the manufacturer authorizes a third party to obtain a duplicate registration certificate (registration certificate duplicate)).