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.
On 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.
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.