Following the publication of the Government Resolution #1517 “On state regulations of prices of medical devices included in the list implantable medical devices approved for state programmes of guarantees on gratuitous medical care in January 2016, Russian authorized representatives of manufactures of implantable medical devices were suggested by Roszdravnadzor, Russian medical device regulator, to provide information for calculation of weighted-average prices of medical devices included in the list. The regulator recommends submitting this information using newly created electronic database not later than 30 days since the day of getting the inquiry.

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On 9 January 2016 the Russian government published it`s Resolution #1517 (link in Russian) “On state regulations of prices of medical devices included on the list of implantable medical devices subject to state reimbursement programses”. The resolution set a deadline as 15 July 2016 for manufacturers or Russian authorized representatives to submit to Roszdravnadzor (Russian medical device regulator) files for registration of the “maximum release prices” of medical devices included in the list.

According to the resolution, the maximum release price proposed by a manufacturer for registration may not exceed the “weighted average price” of the corresponding nomenclature type of medical device defined by Roszdravnadzor according to published method (see clause 3). In the same time, further contract price shall not exceed the registered one.

The timelines for price registration procedure was set as 5 business days.

Related previous posts:

• Russia Set to Strengthen Price Regulations for Implantable Medical Devices

•  Russian Ministry of Health Published the List of Implantable Medical Devices