Dear Regulatory Colleagues,
Please find below my monthly update of important news on medical device regulations in Russia and the CIS region:
1.Ukraine: The Transformation of the Medical Device Regulatory System – Will it be Painful for the Industry?
1 July 2015 is the enforcement date for the new medical device approval procedures in Ukraine. After this, new products will only be able to access the Ukrainian market by conforming to assessment procedures similar to those used by the European regulatory model. The Ukrainian Ministry of Health should promptly adopt additional regulations for the transition to the new regulatory system. It should be remembered that the introduction of new regulations has already been postponed three times in the last several years. Industry players consistently express fears about a possible crisis in the medical device sector in the country due to incomplete legislation covering the transitional period. Another concern of local trade associations is the introduction of mandatory inspection for foreign medical device manufacturers as a part of the assessment procedures for certain types of device. This has a high probability of causing extra delays in market approval due to the lack of qualified inspectors.
2. Russia: Revised Standards on Clinical Trials
A new Russian national standard (GOST ISO 14155-2014 “Clinical trials: Good Clinical Practice” – link in Russian) came into force on 1 June 2015 and replaced the previously enacted GOST R ISO 14155-1-2008 and GOST R ISO 14155-2-2008 standards. This standard has been designed to harmonize with the similar international standard ISO 14155: 2011, which addresses planning, documentation and proper representation of the results of clinical trials to ensure the validity of the data, as well as to protect the rights, safety and well-being of human subjects and define the responsibility of sponsors. It should be highlighted that this standard is highly recommended by Roszdravnadzor (Russian medical device regulator) for clinical trials related to the registration of medical devices in Russia, and it is not applicable to in-vitro diagnostic devices.
3.Eurasian Union: Draft of Harmonized Technical Testing Rules
As is commonly known, the requirements of the technical testing (a form of conformity assessment) for medical devices, as well as requirements for laboratory accreditation, currently differ between Russia, Belarus and Kazakhstan. This means that the results of tests conducted in any one of these countries are not recognized or accepted in the others. On 22 June 2015 the Eurasian commission published a draft of harmonized rules (link in Russian) for technical testing of medical devices, establishing common requirements for technical test procedures across the Eurasian Economic Union (EEU). This document is a second-level guideline which (together with other second level regulations) complement the agreement on the common principles of the circulation of medical devices (link in Russian), which are expected to come into force on 1 January 2016 and thenceforth govern a common market for medical devices in the EEU.
As usual, I would also like to remind you that the objective of this blog is to make Russian and Eurasian medical device regulations clearer. I therefore encourage you to post your comments and questions either here or on the Russian medical device regulations LinkedIn group.
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
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
Ukrainian Government published 12 September 2014 new decree #410 defining the list of medical devices – subjects to 7% VAT for importation in the country. The list will replace old one, published in July 2014, which was significantly wider.
Full list is available in Ukrainian language on: http://zakon2.rada.gov.ua/laws/show/410-2014-%D0%BF
Ukraine, 19 August 2014. Ministry of Health of Ukraine published the Resolution #510 which extend the list of permissions for import of unregistered medical devices, intended for use in military emergency. The Resolution describes the procedure and the list of documents for obtaining such permission.