In accordance with paragraphs B of clause 2 of the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416 “On Approval of the Rules for State Registration of Medical Devices” certificates of registration for medical devices and medical equipment of unlimited validity, issued before the date of entry into force of this Decree, are valid and must be reissued until January 1, 2021 for registration certificates in the form approved by the Federal Service for Surveillance in Healthcare.
The Federal Service for Surveillance in Healthcare on its website additionally draws the attention of subjects of circulation of medical devices to this. If the applicant fails to submit documents to the Federal Service for Surveillance in Healthcare before January 1, 2021 in order to carry out the reissuing procedure, the registration certificate becomes invalid and is no longer valid.
The official website of the Federal Service for Surveillance in Healthcare posted an application form for reissuing the registration certificate.