Category Archives: English

Three Things You Should Know About Medical Device Regulations in Russia, December 2014.

Posted on by
Reply

Welcome to the monthly update on the regulation of medical devices in Russia and let me deliver as usual the three most important news items before we enter the holiday season.

  1. An Eurasian Agreement Defining Common Principles and Rules of Circulation for Medical Devices Was Signed.

On the 23rd of December 2014, Russia, Belarus and Kazakhstan signed a strategic agreement defining common principles and rules of circulation for medical devices. This basic document aims to co-ordinate and harmonize national regulation systems for medical devices across the Eurasian Customs Union (EACU). The agreement was developed based on recommendations from the International Medical Device Regulators Forum. It contains high-level principles that apply throughout the entire life-cycle of a medical device: the manufacturing process, the market access, state registration, post-market surveillance, marking, labelling and quality control. Common medical devices circulation will be implemented from the 1st of January 2016 across EACU, and before this date, this agreement will be complemented by more than 20 subordinate acts/by-laws, which are currently under development. The document is available in Russian on the official website of the Eurasian Economic Commission.

  1.  Russia: Evolution of Drug-Precursor Regulations and Alcohol Regulations for Medical Devices.

For a long time, medical products containing ethanol or drug precursors (e.g. methylmethacrylate), even in a small volume, were subject to restricting regulations in Russia. Importing and circulating such medical devices was made difficult by additional control measures (licensing) on the regulator’s part. These control measures were particularly sensitive to some in-vitro reagents or dental materials. The Russian Government is currently discussing amendments, which will make medical devices an exception from the general alcohol regulations. Thus in the near future one can expect a repeal of licensing procedures for registered medical devices containing less than a 30% concentration of ethanol, or containing ethanol in any concentration if the volume of the containers is less than 10 ml. In relation to this issue, it should be recalled that Russia Signed EU Agreement on Drug Precursors in June and similar amendments were implemented in October this year, decreasing control on small amounts of drug precursors for medical devices.

  1.  Russia: A New Classification of Medical Devices Is Implemented.

On the 26th of December 2014, the Russian Ministry of Health approved and published a new Russian classification of medical devices, based on the GMDN (Global Medical Device Nomenclature) structure . The current classification contains a list of more than 22,000 6-digit codes, with generic descriptors of medical devices divided into 19 sub-groups. The list is available on the official website of Roszdravnadzor (the Russian medical device regulator). The new classification code is meant to be included in all testing reports and registration certificates. It is rather interesting to note that a previously approved list of implantable medical devices subject to state reimbursement programs was already based on this classification structure.

In conclusion of this update I would like to express my sincerest appreciation for your continued readership. From a regulatory standpoint, 2014 was not an easy year for Russia, but I am personally optimistic for the future and would like to wish you the same confidence. Let me express my best and warm wishes for the holiday season and a spectacular New Year!

See you early in 2015.

Seven Court Cases on Medical Devices against Russian Customs

Posted on by
2

As it is known, amendments to the Russian Tax Code in November 2013 have not fully clarified applicability of VAT on importation of medical devices in Russia. While expected low-level legislation changes are under discussion of Russian Government, regional Russian customs posts are very controversial in applying VAT regulations in practice. However, from legal standpoint, exemption from VAT is quite real thing. Here I would like to present a short law review on VAT for medical devices for last year. All information derived from public sources.

  1. Company A vs Tver Customs:
    Date:09.2014 – 21.11.2014
    Decision of The first instance court: to recognize as illegal the decision of Tver Customs to release medical devices with payment of VAT.
    Appeal court upheld the judgment of the court of first instance and left appeal of Tver customs without satisfaction.
    Source
  2. Company B vs Smolensk Customs
    Date: 010.2014
    Decision of The first instance court: to recognize as illegal the decision of Smolensk Customs #XXXX on refusal to grant exemption on VAT for medical devices, to oblige Smolensk customs to pay VAT back
    Appeal court upheld the judgment of the court of first instance and left appeal of Smolensk customs without satisfaction.
    Source
  3. Company C vs Omsk Customs
    Date:08.2014
    Decision of The first instance court: to invalidate the decision of Omsk Customs on calculation of VAT for medical devices.
    Source
  4. Company D vs Moscow Customs (Kashirsky customs post)
    Date: 02.2014
    Decision of The first instance court: to consider as illegal decision of customs post on calculation of VAT rate for medical device as 18%.
    Source
  5. Company E vs Moscow Customs (Sheremetyevo)
    Date: 27.03.2014
    Decision of The first instance court: to consider as illegal and to cancel the decision of Sheremetyevo customs on impossibility of exemption of VAT for medical device.
    Source
  1. Company F vs Moscow Regional Customs
    Date:05.2014
    Decision of The first instance court: to consider as illegal the decision of Istra customs post on refusal to grant exemption on VAT for medical device.
    Appeal court upheld the judgment of the court of first instance and left appeal of Moscow Regional Customs without satisfaction.
    Source
  1. Company G vs Moscow Regional Customs
    Date: 05.2014 – 23.09.2014
    Decision of The first instance court: to consider as illegal the decision of the customs post, to pay back excessively paid VAT for medical devices.
    Appeal court     upheld the judgment of the court of first instance and left appeal of Moscow Regional Customs without satisfaction.
    Source

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

Posted on by
Reply

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.