This is my monthly update with a selection of highlights on medical device regulation changes across Russia and the CIS region.
1. Russia tightens control of medical devices and pharmaceuticals
At the beginning of 2015, Russia implemented amendments to the civil and penal codes and significantly increased penalties on the manufacturing, sale, or trade of counterfeit and unregistered pharmaceuticals and medical devices in accordance with the MEDICRIME European convention signed in 2011. New legislation came into force on 23 January 2015 that enacted stiffer criminal penalties of up to 2,000,000 rubles ($31,000) and a jail term of up to 12 years (for aggravating circumstances) for the manufacturing, sale, or trade of counterfeit pharmaceuticals and medical devices, manufacturing of medical devices without an appropriate license, and forgery of documents accompanying medical devices and pharmaceuticals. The distribution of unregistered medical devices and medical products with characteristics that differ from those declared during registration submission was established as a separate crime as well. In this context, it is to be noted that, according to Mikhail Murashko, head of the Roszdravnadzor (Russian medical device regulator) the number of inspections in the medical device sector will be doubled in 2015.
The text of Federal Law 532 (link in Russian).
2.Russian government is discussing price controls for implantable medical devices.
The Russian Ministry of Health prepared and published a draft (link in Russian) of the regulation, which will introduce a separate procedure for registration and control of maximum sales prices as well as wholesale and retail markups for implantable medical devices on the recently approved list of implantable medical devices subject to state reimbursement programmes. According to the Russian regulator, this measure aims to “solve the problem of destabilization of prices on the market.” Detailed procedures and methods of such controls are not described in the draft, which is open for public discussion until 4 February; nevertheless, the Ministry of Health estimates that this mechanism will come into force at the beginning of 2016 and affect about 10% of the medical devices on the market. Drawing an analogy with Big Pharma, it should be recalled that the Russian implementation of the new law on the circulation of drugs in 2010 resulted in the mandatory registration of prices of drugs listed on the Essential Drug List.
3.Kazakhstan has implemented new safety assessment procedure for medical devices.
The Kazak Ministry of Health published on 21 January 2014 Order #269 on the safety assessment of registered medicines and medical devices (link in Russian).This regulation defines the list of medical devices (which includes wound and surgical dressings, syringes, hemotransfusion/infusion devices, and some others) that are subject to additional mandatory safety assessment procedures in the country. The described procedure is conducted by the National Centre of Expertise on Medicines and Medical Devices by comparing the safety characteristics of the product with data in the registration dossier submitted previously. The regulation provides a list of required documents and sets a maximum timeline for the procedure of 15 days.
If you have questions, comments, or ideas on Russian medical device regulations, I encourage you to post them here or to our group.