Three Things You Should Know about Medical Device Regulations in Russia and CIS, November 2014

At the end of this year, one may see a very slow recovery leading into a positive dynamic for Russian regulators of medical devices: the number of registration approvals is increasing and registration steps are gradually becoming shorter. Active work is continuing for the completion of the upcoming harmonization of regulations between Russia, Belarus and Kazakhstan. Below, please find my monthly selection of regulatory highlights for Russia and the CIS region:

1.”Falling Up”

“Medical Device Market: Falling Up” is the slogan of the strategic session chaired by Russian Ministry of Industry and Trade on the 12th of November as a part of the Medica 2014 exhibition in Dusseldorf. More than 100 industry representatives had a chance to get first-hand information about upcoming changes in medical device regulation in Russia directly from top-level officials as well as to discuss strategic scenarios and investment climate for the industry. The focus of this session was on localization and import regulation programs for medical products in Russia. The key strategic message from the regulator remains unchanged – “40% of medical devices for state procurements to be manufactured within Russia till 2020”.
According to Sergey Tsyb, Deputy Ministry of Industry and Trade, “This proposal has been already submitted to the Government of Russian Federation and we hope that it will be signed off within the month. There is special attachment to this document—the list of medical devices, which are already manufactured in Russia. And if there are two or more Russian analogues, this order will allow Russian manufacturers to compete in supplying their products for the Russian healthcare system”.

2. Advertising of Medical Devices across CIS

On the 20th of November, law #203-5 of Kazakhstan (signed in May 2014) came into force, amending Article 18 of National Health Code on the advertising of medical products. According to these changes, advertising medical products (including medical devices and medical equipment) via mass media henceforward is prohibited; rather, such advertisements can be placed only in specialized medical publications or health facilities. Previously, both medical devices and medicines could be advertised only if authorized by the Kazakhstan Ministry of Health according to special procedures; this has been now cancelled per the amendment above.Moreover, it should be noted that similar changes had been rejected in August 2014 by Russian regulators but are currently under intense discussion in Ukraine.

3. Federal Law on Circulation of Medical Devices…Attempt Number Three

The third version of the draft of Federal Law on the Circulation of Medical Devices became available for public discussion in November. Unlike the previous version of the law, which had been proposed by the Ministry of Health and had received controversial feedback from experts, the new version of the regulation was presented by the Ministry of Industry and Trade of Russian Federation. The text of the law has been considerably expanded, especially in the description of the registration process of medical devices. Apparently, the draft will be submitted to the government for approval within weeks, and the law should be enacted by the end of the year. However, work on it is expected to continue through 2015, as it requires harmonization with upcoming changes in regulations concerning medical devices per the Eurasian Customs Union.

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