Issuing a Duplicate Medical Device Registration Certificate

Grounds for requesting a duplicate medical device registration certificate are based on the Rules for State Registration of Medical Devices, approved by the Resolution of the Government of the Russian Federation dated December 27, 2012, No. 1416 (section 52):

• In case of loss of the medical device registration certificate;
• In case of damage to the medical device registration certificate.

The timeframe for issuing a duplicate registration certificate for a medical device is 7 working days.

Documents and information provided for the issuance of a duplicate medical device registration certificate include:

• Application for issuing a duplicate registration certificate for a medical device, in the format approved by the order of the Ministry of Health of Russia dated October 14, 2013, No. 737n “On the Approval of the Administrative Regulation of the Federal Service for Surveillance in Healthcare for the Provision of State Service for the State Registration of Medical Devices.”

The application form is available on the official website of Roszdravnadzor at www.roszdravnadzor.гu . All information in the application should exactly match the information in the lost (damaged) registration certificate.

• Information about the payment of the state fee for the procedure of obtaining a duplicate registration certificate for a medical device, which amounts to 2,500 rubles.
• The damaged registration certificate for the medical device (in case the registration certificate for the medical device is damaged).
• A power of attorney from the manufacturer of the medical device for issuing a duplicate registration certificate, with a translation duly certified into Russian:

1. indicating the reason for obtaining a duplicate registration certificate for the medical device;
2. empowering to represent the manufacturer’s interests regarding the circulation of medical devices in the Russian Federation.

It is possible to provide a letter from the manufacturer of the medical device stating the reason for obtaining a duplicate registration certificate for the medical device.

• Information on the revocation of the previously issued power of attorney/notification to the applicant at the initial registration about receiving a duplicate registration certificate by a third party (in case the manufacturer has authorized a third party, not named in the registration certificate (registration dossier), to receive the duplicate).