Dear colleagues and group members,
Let me share the latest news and updates on medical device regulations in Russia CIS and countries of the Eurasian Economic Union (EEU). Here are my three highlights from April 2016.
- Prolongation of the Transitional Period in Ukraine.
At the beginning of April 2016, the Ukrainian government published the text of Decree # 240 (link in Ukrainian), which extended by one year (until 1 July 2017) the transitional period for medical devices registered in the country before July 2015 in accordance with the “old” medical device approval system. The document also stipulates that, if a registered medical product has a valid registration certificate that expires before the 1st July 2017, that product must pass a new conformity assessment procedure, either after the expiry date of this certificate or during its validity period (the former option was not previously possible due to a gap in the law). At the moment, more than ten notification bodies operate in Ukraine under the new procedure that came into force in July 2015.
- Roszdravnadzor on Price Regulation for Implants
In April 2016, Roszdravnadzor (the Russian medical device regulator) finished collecting information from medical device manufacturers on prices for implantable medical devices.
As announced in Roszdravnadzor’s seminar on the 27th April 2016, information on the prices of implantable medical devices has been provided to the regulator by 68 Russian companies. On the basis of this information, “weighted-average” prices will be calculated and published by for each type of implant in the coming weeks. The Russian medical device agency highlighted that, according to Resolution #1517 (link in Russian), all applications for the registration of prices must be submitted by manufacturers before the 15th July 2016 (but not before the “weighted-average” prices have been published).
It should be noted that, according to Resolution #1517, submitted prices cannot exceed the published “weighted-average” prices, and implantable devices with unregistered prices will not be included in government healthcare programmes from 2017 onwards.
At the same time, Roszdravnadzor provided information about the forthcoming expansion of the list of implantable medical devices subject to national healthcare programmes.
- Amendments to Resolution #102 on Access Restrictions for Certain Types of Medical Products.
On the 22nd April 2016, the Russian government published Resolution №337, which gave details of a number of amendments and refinements to Resolution №102 “On Establishing Access Restrictions for Certain Types of Foreign-Made Medical Products”. In accordance with Resolution №102, which was published in February 2015, Russian customers have to reject an application for the state procurement of medical devices made by foreign manufacturers from the restriction list (with the exception of countries in the Eurasian Economic Union) if at least two bids were filed for participation in the tender by local manufacturers. The new regulations set a prohibition on inclusion in the same bid in the tender medical devices included in the restriction list and is not included in it. In addition to this, the new resolution prohibits changes being made to the manufacturer or country of origin of medical devices during contract execution.
The objective of this blog is to make Russian and Eurasian regulations clearer. Please post your comments and questions here or on the Russian medical device regulations LinkedIn group. You can also follow me on twitter @MedDevRus.