The Federal Service for Supervision in Healthcare Informs about the adoption of the Resolution of the Government of the Russian Federation of 31.05.2018 No. 633 “On Amending the Rules for the State Registration of Medical Products“.
The Government Decree amended the Rules for the State Registration of Medical Devices, approved by Resolution No. 1416 of the Government of the Russian Federation of December 27, 2012, which will allow:
– simplify the registration procedure for products for in vitro diagnostics (a one-stage registration procedure was introduced);
– bring into compliance with the requirements of the EAEC the requirements for documents confirming the quality of the medicinal product and pharmaceutical substance contained in the medical device;
– bring the procedure for introducing changes in the registration certificate and the registration dossier for the medical device in accordance with the standards of the EAEC;
– delete the form of the medical device from the form of the registration certificate in accordance with the nomenclatural classification by types with the simultaneous introduction of a mechanism that allows the producer to be notified of a change in the species code;
– an individual entrepreneur to be a legal entity in whose name a registration certificate may be issued, as well as an authorized representative of the manufacturer.