Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, February 2016


Dear fellow colleagues,

Let me deliver my selection of highlights on the status of the regulation of medical devices in Russia and the Eurasian Customs Union in February:


  1. Price regulation for implantable medical devices in Russia
    One of the most significant topics is the development of price regulations for implantable medical devices for state programmes of guarantees on gratuitous medical care. Following the publication of Government Resolution #1517 in January 2016, on 10 February 2016, Roszdravnadzor (Russian medical device regulator responsible for price regulation and control) published a list of 412 manufacturers, Russian authorised representatives and distributors to whom it will be sending requests to provide information for the calculation of weighted-average prices regarding the medical devices included in this The regulator recommends submitting this information using a newly createdelectronic database no later than 30 days following the day of receiving the inquiry. In parallel, the Russian Ministry of Health has clarified some categories on the list of implantable medical devices subject to price regulations (see the clause below).


  1. Amendments to Russian Public Health Protection Federal Law
    At the start of February 2016, The Russian Ministry of Health suggested a number of amendments to the Russian Federal Law 323 on Public Health Protection in the Russian Federation (link in Russian). Though this law is extremely high level and fundamental healthcare act, some of these amendments are relevant to medical devices:
  • Extension of the number of cases when a medical device needs no registration or is allowed to be imported into Russia unregistered; e.g., medical devices imported for research and scientific needs, forensic medicine, trade exhibitions, as well as for vital requirements for a particular patient (using special permissions).
  • The draft introduces the definition of an implantable medical device, which is in line with similar internqtional GHTF definition
  • The draft clarifies categories of implantable medical devices subject to price regulations.

This legal initiative is not yet adopted and is currently in the development phase; the draft can be traced online via the official Russian regulation web portal.

  1. Status of Eurasian Medical Device Integration
    Eurasian integration – how does it work in practice? Though common Eurasian medical device and pharmaceutical regulations formally came into force in January 2016, for the time being, no information is available from member states pointing to the fact that applicants can take advantage of new registration During the Eurasian session of the seminar held by Roszdravnadzor on 4 February 2016, the speaker from the Eurasian Commission reviewed the status of second and third level regulations, and it was announced that these would take effect in March 2016. Also confirmed was the transition period of five years during which a manufacturer will be able to chose either to submit using “old” national or “new” Eurasian processes; previously, the timeline for the transition period had been interpreted ambiguously.

In this blog, I will keep an updated focus on imitative strategic Eurasian medical device updates, as well as on other regulatory updates, which you can follow using WordPress, Twitter or the LinkedIn group.

Alexey Stepanov



Thirty days to provide information on prices for implantable medical devices

Following the publication of the Government Resolution #1517 “On state regulations of prices of medical devices included in the list implantable medical devices approved for state programmes of guarantees on gratuitous medical care in January 2016, Russian authorized representatives of manufactures of implantable medical devices were suggested by Roszdravnadzor, Russian medical device regulator, to provide information for calculation of weighted-average prices of medical devices included in the list. The regulator recommends submitting this information using newly created electronic database not later than 30 days since the day of getting the inquiry.

Related previous posts:

Russia is among the Most Difficult Markets to Enter

Based on the responses of 2,062 industry professionals published in the Global Medical Device IndustryOutlook for 2016 by Emergo Group, Russia and China traditionally was most often cited as more difficult markets to enter.

58 percent of respondents consider that the process of obtaining regulatory approval for a medical device in Russia in 2015 became more difficult than before and only 2 percent of professionals believe that situation became better.



In the same time Roszdravnadzor (Russian medical device regulator) in December 2015 said about “good dynamics” and showed positive trends in medical device approvals.


Data published with kind permission of Emergo Group