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.

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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.