The Ministry of health of Russia has developed amendments to the Decision of the Council of the Eurasian economic Commission dated February 12, 2016 No. 46 “On Rules of registration and examination of safety, quality and effectiveness of medical devices”.
With the aim of bringing to uniformity requirements of the Agreement and the establishment of equal conditions for admission to treatment for all producers (or their authorized representatives), as well as to preserve the possibility of using duly registered in the member state medical devices for all users of medical devices (medical organizations, citizens) in the territory of that member state proposed in the transitional period until 31 December 2021 to permit the registration of a medical device and (or) amendments to registration dossier of medical devices by the manufacturer of the medical device (its authorised representative) in accordance with the Rules or in accordance with the laws of the member States of the Eurasian economic Union.
Also, in accordance with the amendments, medical device, registered in accordance with the legislation of a member state after the Agreement enters into force, apply in the territory of that member state before the expiry of the documents confirming their state registration, issued by the competent authorities of the member States in accordance with the legislation of these member States.
It is expected that the decision will come into force on 1 January 2019.
Public discussion of the draft document is posted on the website regulation.gov.ru until 31 August 2018.