Russia Enforced Price Regulation for Implantable Medical Devices

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:

2 thoughts on “Russia Enforced Price Regulation for Implantable Medical Devices

  1. Pingback: Thirty days to provide information on prices for implantable medical devices | Medical Device Regulations in Russia and Eurasian Union

  2. Pingback: Five Things to Know about Medical Device Regulations in Russia in 2016 | Medical Device Regulations in Russia and Eurasian Union

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