In pursuance of the amendments to the Agreement on Common Principles and Rules for Circulation of Medical Devices (Medical Products and Medical Equipment) Within the Eurasian Economic Union dated December 23, 2014, amendments can be made to the registration dossier of a medical device in accordance with national regulations until December 31, 2026.
Registration dossier is subject to amendment where it is necessary to amend the technical and operational documentation (save as listed in sub-paragraph “d”, paragraph 37 of Government Decree No. 1416 dated December 27, 2012). Such amendments are based on results of the quality, efficacy and safety examination of a medical device executed in a manner similar to the procedure for the quality, efficacy and safety examination of a medical device for the state registration of such devices, if the registering authority, after having verified the completeness and accuracy of the data contained in the submission, finds that such amendments will result in a change in the properties and characteristics that affect the quality, efficacy and safety of the medical device, or will improve its properties and characteristics with the functional use and/or the principle of operation of the medical device remaining unchanged. State fees are payable following the laws of the Russian Federation on taxes and duties subject to the risk class of the medical device.
Replacement of a registration certificate does not require undergoing state registration of the medical device and is based on an application submitted by the applicant to the Federal Service for Surveillance of Healthcare, indicating information provided in the Rules approved by this Decree.
In case of loss or damage of a registration certificate, the applicant is eligible to file an application to the Federal Service for Surveillance of Healthcare for a duplicate of the registration certificate. In case a registration certificate is damaged, the damaged registration certificate must be attached to the application for a duplicate. The state fee for a duplicate registration certificate is RUB 1,500.
Amendments to be made to registration dossier of medical devices that do not require new registration:
Forms of applications for making amendments to the registration dossier, cancellation of the registration certificate, or a duplicate of the registration certificate are given in the Annexes to Resolution 46 of the EEC Council.