February 16, 2017
Tenure of infinite registration certificates for infinite medical devices prolonged until 2021
The term of validity of registration certificates for infinite medical devices was prolonged until 2021. The relevant resolution of the Russian Government No. 160 dated February 10, 2017 under the title “On introducing changes in the Resolution of the Government of the Russian Federation No. 1416 dated December 27, 2012” has been signed by Russian Prime Minister Dmitry Medvedev.
It is to be reminded that, in accord with the Resolution of the Government of the Russian Federation No. 1416 dated December 27, 2012 “On approval of the Rules of State Registration of Medical Devices”, the registration certificates of medical devices and technical equipment of infinite service life, issued before the effective date of the aforesaid resolution, were subject to substitution for registration certificates of the form, approved by the Russian Federal Service for Surveillance in Healthcare. This measure coming in force was planned to take place on January 1, 2014, but was deferred to January 1, 2017 after appeals of makers.
The already effective resolution of the Russian Government prolonged the deadline of replacement of the registration certificates for four years more, until 2021.
For reference by the Federal Service for Surveillance in Healthcare: from 2013 through 2016, the Federal Service for Surveillance in Healthcare received above 14,000 applications for substitution of registration certificates (above 8,000 were filed in 2016 only), and above 10,000 registration certificates were re-issued in accordance with results of their consideration.
