Monthly Archives: August 2017

Law on Circulation of Medical Devices in Kyrgyzstan

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At the beginning of August 2017 Kyrgyz president signed the law “On Circulation of Medical Devices”.  Draft of this law was published previously (link in Russian).
The published law introduced definition and classification of medical devices (harmonized with Eurasian regulations) and requirements for registration, clinical trials, manufacturing inspections and safety monitoring (post market requirements).

Since 2015, Kyrgyzstan is a member of Eurasian Economic Union, but until today country didn’t have dedicated medical device regulations.

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Russia Implemented New Scheme for Public Procurement of Plastic Consumables

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Intravenous-Product-Packaging.jpgOn 17 August 2017, the Russian government published the resolution #968 (link in Russian) and introduced a new scheme for public procurement of consumables medical devices made from polyvinyl chloride plastics on the Russian market. Published document  seriously amends the  previously adopted Resolution No. 102 of the Russian Government dated 5 February 2015 “On Establishing Access Restrictions for Certain Types of Foreign-Made Medical Products to Procurements for State and Municipal Needs” completing  it with “the list #2″ of medical devices  made from polyvinyl chloride.

List #2 contains six groups with 86 types of plastic consumables classified using Russian nomenclature system: blood storage  products, consumables for plasmapheresis,  pulmonary ventilation and heart-lung machines, urine/colostomy bags.

According to the document, the preference in public procurement of products from the list #2 henceforward will be given to those companies that invest in specialized production on the territory of Russia according to previously published criteria (link in Russian).

The document will come effective on 25 August 2017.

Extension of the List of Implants for National Healthcare Programs

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On 31 July 2017 the Russian government published the Resolution #1587-r (link in Russian) and extended the list of implantable medical devices for national free healthcare aid programs. The existing version of the list with 359 types of implantable medical devices (link in Russian) have been completed by new 23 types of devices  most of which are intended for preparation for surgical interventions as well as delivery, fixation and extraction of implants.

Initially, the list was implemented in the end of 2014, and for today, according to Russian Federal Law 323-FZ, presence of a product in the list is a mandatory requirement for  its participation in national healthcare programs. Products in the list are subject of maximum sales prices and maximum mark-ups regulation in Russia.