It is time for a monthly update and here are the most important medical device regulatory initiatives and changes for Russia, the Eurasian Customs Union (ECU) and the CIS region for March:
1. Russia: Price Regulation for Implantable Medical Devices for State Procurements
On 9 March 2015 the Russian president signed an amendment (link in Russian) to article #80 of the Russian Federal Law #323 “On the Fundamentals of Health Protection in the Russian Federation”. These amendments introduce additional price regulations for implantable medical devices included in the recently approved list of implantable medical devices subject for national reimbursement programmes. Roszdravnadzor (a Russian medical device regulator) launched a website for the weekly monitoring of price dynamics for implantable medical devices. The regulator is expected to be responsible for the registration of manufacturers’ maximum sales prices, maximum wholesale and retail mark-ups and the maintenance of the national open public register with this information. The draft of the detailed guidance for this initiative (the methodology for determining the maximum wholesale producer prices for medical devices) will be available (link in Russian) for public discussion by 19 April 2015 on the official online database of the federal executive authority and is expected to come into force within Q2 2015.
2. Eurasian Customs Union: End of the Transition Period for EAC Conformity Assessment Procedures
15 March 2015 was the day when the transition period for several technical regulations of the ECU ended, among them TR TS 020/2011 “Electromagnetic compatibility” (link in Russian) and TR TS 004/2011 “On safety of low voltage equipment” (link in Russian). Since 15 March 2015, manufacturers and importers who release into circulation on the ECU market products (including medical devices) covered by these technical regulations will have to undergo a new conformity assessment procedure (an EAC procedure according to the requirements of the ECU technical regulations above instead of the GOST-R assessment procedure in Russia).
3. Ukraine: Simplified Registration Track for Certain Medical Products
On 19 March 2015 the Ukrainian Parliament approved Law #2150 (link in Ukrainian). This law provides a separate temporary mechanism to engage specialised international organisations and funds (among them the International Dispensary Association, Crown Agents, Partnership for Supply Chain Management, and others) in the procurement of certain medicines and medical devices on the basis of a special agreement with the Ukrainian Ministry of Health. The law introduces a simplified and fast-track (up to 14 days) registration procedure for certain medicines and medical devices that are to be procured by these organisations and allows them to be classified as essential medical products for subsequent release from additional import duty.
The objective of this blog is to make Russian and Eurasian medical device regulations clearer. Please post your comments and questions here or on the Russian medical device regulations Linkedin group or follow me on twitter @MedDevRus