Roszdravnadzor: statements by medical device manufacturers about possible problems in 2017 are unfounded

In connection with the media-disseminated information about possible problems in the medical device market in 2017, Roszdravnadzor has the following to say.All medical devices (products intended for medical use and medical equipment) at present have open-ended registration certificates in Russia.

In 2012, the Government of Russia prescribed that manufacturers having obtained a registration certificate (RC) before that moment should replace the RC before 1 January 2014 with a new one from Roszdravnadzor (Order of Russian Government No 1416 “Rules of State Registration of Medical Devices”).

At the end of 2013, the deadline was extended at manufacturers’ requests until 1 January 2017. It should also be noted that between 1 January 2013 and 24 August 2016 the Federal Service for Supervision in Health Care received fewer than 9,200 applications for replacement of a registration certificate (out of the 37,500 RC that need to be updated).

Replacement of a registration certificate takes 30 days. Thus manufacturers have at present enough time to obtain new registration certificates, so talk about possible problems in the medical device market for bureaucratic reasons is unfounded. Timely renewal of documents is the responsibility of the manufacturers themselves.

In any case, the Ministry of Health of the Russian Federation will carefully consider the proposal of the International Medical Device Manufacturers Association (IMEDA) concerning the need for extending the RC replacement deadline and give the answer within the time required by the law.