The Government has simplified the rules of State registration of medical devices
The Federal Service for Surveillance in Healthcare informs about the adoption of the decree of the Government of the Russian Federation dated 31.05.2018 № 633 “On amendments to the Rules of State registration of medical devices”.
The Government decree amended the Rules of State registration of medical devices № 1416 which were approved by the Government of the Russian Federation on 27.12.2012. These changes will allow:
– To simplify the registration procedure for products for in vitro diagnostics (a single-stage registration procedure is introduced);
– To bring the documents, confirming the quality of the drug and pharmaceutical substance in the composition of medical device, into compliance with the norms of the EAEU requirements;
– To bring the procedure of making changes in the registration certificate and the registration dossier of a medical device in accordance with the norms of the EAEU;
– To exclude the type of a medical device from the form of registration certificate in accordance with the nomenclature classification by type with simultaneous introduction of the mechanism, allowing to notify the manufacturer about change of the code of the type;
– Individual entrepreneur to be a legal entity in whose name the registration certificate may be issued, as well as the authorized representative of the manufacturer.