Pursuant to Subparagraph (b) of Paragraph 2 of Decree of the Government of the Russian Federation No. 1416, dated December 27, 2012, "On Approval of the Rules for State Registration of Medical Devices," perpetual registration certificates for medical products and medical equipment issued prior to the effective date of this Decree remain valid and are subject to mandatory replacement before January 1, 2021, with registration certificates issued in accordance with the standard form approved by the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Roszdravnadzor has issued an additional alert on its official website to remind medical device market participants of this requirement. If an applicant fails to submit the necessary documentation to Roszdravnadzor to execute the replacement procedure before January 1, 2021, the legacy registration certificate shall expire and cease to be valid.

Roszdravnadzor has published the official application form for registration certificate replacement on its website.