Three Things You Should Know about Medical Device Regulations in Russia, August 2014

Dear Fellow Colleauges,

At the beginning of my monthly update, I would like to provide some numbers reflecting the activity of the Russian regulator. According to the official Rosdravnadzor site, for the period between 1 and 25 August, 120 registration certificates – both renewals (major part) and new registrations – have been approved, of which 38 approvals for Russian manufacturers. More than 70 unregistered medical devices have been suspended. 102 authorizations for clinical trials and 73 permits for samples importation were issued.

 

  1. New Details on Common Eurasian Medical Device Regulations Emerged:
    Following the fact that the Treaty on the Eurasian Economic Union (EAU) was signed by Russia, Kazakhstan and Belarus on 29 May, the Eurasian Economic Commission (EAEC) published on 11 August the draft of the agreement on common regulations on medical devices for the EAU.
    According to the draft, one registration certificate is anticipated to be valid throughout the whole EAU territory as far as testing performed in one country will be accepted within the Union. The EAEC expects this agreement to come into force on 1 January 2016, and after this date, current (local) registration certificates will be valid until their expiry dates or, if there is no expiry date, until 31 December 2021.
    The draft of the regulations implies a common approach on vigilant data collecting and reporting (a reporting period of five days was set) and labelling (special symbols will be required) for medical devices approved for the EAU.
  2. Coming Regulations on State Procurements of Medical Devices in Russia: “Constraints” Replaced “Strict ban”.
    After the negative feedback from medical and business associations on the draft of the Resolution on “On establishing a ban on individual types of medical devices originating from foreign countries for State and Municipal procurements”, the Russian Ministry of Industry and Trade (Minpromtorg) has officially announced the revision of its position. The term “strict ban” for state procurements for certain groups of medical devices has been replaced with the term “constraints”. The new version of the document assumes that foreign manufacturers will be able to participate in public procurement in the case when fewer than two bids from EAU manufacturers have been submitted for tender. These limitations do not extend to all medical devices, but only to a certain list of products, which has also undergone some changes: some X-ray equipment have been excluded from the list, meanwhile ECG, refrigeration equipment, diagnostic test kits and reagents have been added. It was also highlighted that conformity to the ISO 13485-2011 standard is necessary for EAU manufacturers in order to participate in state and municipal procurements.
  3. New Edition of the Registration Rules in Russia:
    New amendments to the registration rules (Resolution 1416) came into force on 29 July. The most positive outcome is the possibility to eliminate faults during experize phase. Previously there was no such option and any discrepancy in the dossier revealed by the regulator during expertise usually led to an official refusal of registration. On the other hand, some important and broadly-discussed suggestions for improvement, such as fast-track approval for first class medical devices and special procedures to renew expiring registration certificates, have NOT been approved. The new edition of the registration rules slightly extends timelines and reasons for renewals and requires the provision of clinical data in the registration dosser (not before clinical trials as it was previously).

 

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