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

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.

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