Here is my monthly newsletter with the most important regulatory updates on medical devices in Russia and the Eurasian Union for August 2018.
1. Potential Changes in the Eurasian Medical Device Transition Period for certain group of devices
On 6 August 2018, the Eurasian Commission published a draft regulation (link in Russian) that suggests prolongation of the validity of the medical device registration certificates of Eurasian member states for certain group of devices after the end of the Eurasian transition period.
According to Article 11 of the Agreement on the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union (signed on 23 December 2014 and enforced on 12 February 2016), registration certificates issued by member states prior to the date of enforcement of the agreement are valid no later than the end of the transition period set as 31 December 2021.
The published draft proposes that medical devices registered by Eurasian member states after the date of the enforcement of the Agreement may be in circulation in that member state until the expiration date of the registration documents.
Thus, in case of approval, this document will allow the Eurasian registration deadline of 31 December 2021 for medical devices registered in Russia and other member states after 12 February 2016 to be disregarded.
2. Memorandum of Understanding on Medical Device Nomenclature
Another interesting update on the development of Eurasian medical device regulations is the draft memorandum (link in Russian) of understanding between the Eurasian Economic Commission (EEC) and the Global Medical Device Nomenclature Agency (GMDN), published by the EEC on 21 August 2018. This document publicises the collaboration and exchange of information between the two agencies with the objective of harmonisation and actualisation of Eurasian and GMDN nomenclature.
You will recall that several regulations on Eurasian medical device nomenclature classification have already been adopted and enforced: Eurasian regulation #177 (link in Russian), adopted in 2015, and Eurasian regulation #46 (link in Russian), adopted in April 2018.
3. Update on the Russian Standard for Medical Device Ethylene Oxide Sterilisation Requirements
On 1 September 2018, the new version of the Russian national standard GOST ISO 11135-2017 ‘Sterilisation of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilisation process for medical devices’ (Link in Russian) will replace the old version (GOST ISO 11135-2012). The new version of the GOST standard is identical to the international EN ISO 11135:2014 and sets out how to ensure that medical devices are sterilised effectively, using an ethylene oxide sterilisation process. The new version of the Russian standard should be considered during pre-registration testing, and files submitted for registration after the date of enforcement.