It’s a quite a good news for IVD manufacturers… In the first days of June 2018, the Russian Government released the resolution #633 (link in Russian) and approved significant multiple changes in the procedure of registration of medical devices in Russia:

• Simplification of the registration process of in-vitro diagnostics (IVD) proposing one-step expert assessment (expertise) for registration instead of the current two-step pathway. All classes IVDs pass henceforward through simplified registration process by analogy with class I and non-sterile class IIa medical devices;
• Significant changes for the list of reasons, requirements and timelines for regulatory renewals (amendments of the registration certificates and amendments of documents of the registration dossier) for already registered devices; the list of cases when expert assessment (expertise) is not required for re-registration was clarified;
• Update of requirements for documents of registration file for IVDs and medical devices with pharmaceutical component;
• Extension of the list of reason for registration rejection and cases when registration certificate may be withdrawn/annulled;
• Other minor amendments on registration procedure e.g. requirement of providing information of trademark, clarification of number of possible additional document requests from the assessment body and clarification of administrative requirements for the applicant…

Overall,  the amendments of the resolution #633 harmonise Russian medical device registration requirements with Eurasian regulations and aimed to simplify IVD and MD approval process.