
Duplicate of registration certificate In Russia
The procedure for receiving a duplicate of the registration certificate (RC) is regulated by paragraph 52 of the Decree of the Government of the Russian Federation dated 27 December 2012 N 1416 "On Approval of the Rules for State Registration of Medical Devices" (Order 1416). A duplicate is issued if the original RC is lost or damaged. In case of damage to the original RC it is necessary to submit the damaged original to Roszdravnadzor. Receiving a duplicate of the RC is an easy and quick procedure (the period of issuing a duplicate is 7 working days), under the condition of receiving confirmation of the absence of the original RC from all interested bodies. The interested bodies in this case are: the manufacturer itself, AR, the person in whose name the RC was issued (the holder of the RC). If the holder of the RC is not the manufacturer himself and in the absence of confirmation from the holder about the loss of the original RC, the process of receiving a duplicate can be significantly complicated. When submitting a statement for issuing a duplicate, all information must exactly match the issued RС. Receiving a request from the RZN to correct/add information is not provided by the Order 1416.