Tag Archives: Kazakhstan

Three Things You Should Know about Medical Device Regulations in Russia and CIS, January 2015

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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.
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If you have questions, comments, or ideas on Russian medical device regulations, I encourage you to post them here or to our group.

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

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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.

Kazakhstan has introduced a system of accelerated registration of medical equipment

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System accelerated registration of medical equipment introduced in order to improve their state registration procedures, as well as access to health care organizations innovative medical technology. Now, medical equipment, which is certified international expert organizations that have concluded an agreement with the competent authority in the field of health, will rapidly be registered within 5 working days. Earlier this period was 120 days. In the city of Munich (Germany) signed a Memorandum of Understanding between the Ministry of Health and by TUV SUD Product Service GmbH, which provides European quality certificate, which is mandatory for the admission of goods into the European market. The Agreement provides for bilateral cooperation in the field of medical technology through the exchange of experience in assessing the quality of production of medical devices, information in the registration of medical technology and express check in Kazakhstan medical technology with a certificate of TUV SUD Product Service GmbH. With this amendment the Kazakhstan market opens for the world’s top manufacturers of medical equipment.
Source: http://www.mz.gov.kz