Three Things You Should Know about Medical Device Regulations in Russia and CIS, April 2015

As usual at the end of the month, I would like to share my selection of highlights on what is going on with the regulation of medical devices in Russia, the Eurasian Customs Union, and CIS countries:


  1. Russia has published a 5-year import substitution strategy.
    The Ministry of Industry and Trade of the Russian Federation (MinPromTorg) approved the 2nd April 2015 strategic 5-year plan for import substitution in the pharmaceutical and medical device industry. Within this plan, there is a list (link in Russian) of one hundred and eleven groups of medical devices detailing targeted market shares of foreign manufacturers by 2020. Among them, for example, are surgical disposable materials (target is 40% imports in 2020, compared to 90% at the moment), prostheses, endoprostheses and their parts, cardio pacemakers (10% import in 2020 vs. 85% now), endoscopes (35% vs. 100%), X-ray equipment, and other groups of medical devices. It is to be noted here that the National program for the development of the pharmaceutical and medical industry approved last year’s target of a 40% market share of all medical devices to be manufactured in Russia by 2020.
  2. Kazakhstan has changed the registration procedures.
    In April, the Ministry of Health of Kazakhstan published changes in order №735 of the registration of medicines and medical devices and medical technique equipment (link in Russian) and order №736 for expertise in pharmaceuticals and medical devices (link in Russian). The relevant authorities in Kazakhstan held a seminar explaining the new rules.
    The main changes in procedure include a requirement of expertise of a medical device prior to a submission for registration and introduction of a mandatory electronic registration dossier.
    From April 2015, all registration documents will only be accepted in electronic form. In the process for expertise and registration, the electronic dossier will be updated with the conclusions of experts at all stages of examination, as well as with additional materials. It should be recalled that Kazakhstan has a separate procedure for medical equipment (technique) and medical devices and requires separate registration for every manufacturing site.
  3. Medical device mark for Eurasian Economic Customs Union.
    In April 2015, the draft ( link in Russian) of a special mark for medical devices marketed in the Eurasian Economic Customs Union (EECU) became available on the website of the Eurasian Economic Commission.Screenshot_1
    It is expected that before the release of a medical device for circulation in the EECU, the manufacturer or their authorised representative will mark the medical device with this mark (the device, individual packing, and instructions for use should be marked), if the device passed the newly established registration procedure. Let me remind you that the agreement on common principles of the circulation of medical devices, signed in December 2014, implies the harmonisation of registration and labelling requirements, circulation, and post-market surveillance for medical devices across Russia, Belarus, and Kazakhstan from the 1st January 2016.

I would also like to use the opportunity of this update to thank all blog readers and group members for following and invite you to join my presentation on upcoming EECU medical device regulations at the Informa Regulatory Affairs in Emerging Markets conference in June 2015.

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