I hope your Russian regulatory projects are going well! Let me deliver my monthly update of the most important regulatory news for Russia, CIS and the Eurasian Customs Union:
- Ukraine: should current medical device registration certificates be renewed?
1 July 2015 is the enforcement date for the new medical device approval procedures in Ukraine. After this date, the access of new products to the Ukrainian market is expected to be possible only by obtaining a special mark, achieved by conformity with the new technical regulations such as:
-technical regulation #753 – Medical devices (link in Russian)
-technical regulation #754 – In vitro diagnostic devices (link in Russian)
-technical regulation #755 – Active implantable medical devices (link in Russian)
The deadlines for mandatory application of technical regulations has been repeatedly postponed since 2011, but according to the message from the Ukrainian Ministry of Health, this year the Regulator is going to adhere firmly to the announced date and does not recommended another postponement.
Last month the Ukrainian government approved decree №181 (link in Russian), which establishes a procedure for the transitional period until 1 July 2015. After 1 July 2015, the admission of products already registered in Ukraine is expected to be permitted until 1 July 2016 or until the expiration date of the relevant product’s registration (if this date is earlier than 1 July 2016).
Meanwhile, Ukraine has recently established a temporary exemption from VAT and fast track registration for certain medical devices imported and/or supplied on the basis of agreements with qualified international procurement agencies.
- Strengthening price regulation for implantable devices in Russia
Amendments to the Federal Healthcare Act (link in Russian), signed in February, are aimed at strengthening the regulation of prices for implantable medical devices. These amendments officially came into force on 9 May 2015. These amendments have introduced price registration, monitoring and control for implantable medical devices included in the list of implantable medical devices subject for national reimbursement programmes. Despite the fact that these amendments are now in force, the law is not yet effective due to a lack of secondary legislation (i.e. a description of the price registration procedure and methodology for determining the maximum wholesale producer’s prices for medical devices) which are at the stage of approval and are expected within the coming weeks.
- Status of the Eurasian Medical Device Harmonisation
At the meetings of the working group of the Eurasian Economic Union (13-15 May 2015 in Almay (Kazakhstan)) it was confirmed that there may be a “high degree of readiness” of a major part of second-level regulations for common medical device regulations, which is expected to come into force on 1 January 2016. The draft rules of registration and expertise of medical devices proposed previously by Kazak regulators as well as the requirements for its implementation maintain the quality management system for medical device manufacturers are approved with some additional recommendations. Documents will be available on the official website. For now, three guidelines for new medical device systems are already approved and available: 1. classification according to safety class (link in Russian), 2. essential principles of safety and performance (link in Russian) and 3. requirements for EAC mark (link in Russian).
Let me take advantage of this update as well to thank you for following this blog and invite you again to register and to ask your questions in the new Russian Medical Device Internet Forum which you can find at the top of this page //www.medicaldevicesinrussia.com/ or http://meddevrus.listbb.ru