October 2014 was remarkable with a series of “big events” on the Russian regulatory landscape which opened up possibilities to get first-hand information from Russian regulatory bodies: a public seminar by Roszdravnadzor on clinical trials, a big conference “Farmmedobrashenie” and a public discussion on “Federal Act on Medical Devices”.
The first interesting statistics on registration of medical devices for this year appeared: the Head of Medical Device registration department announced that there were 1176 positive and 428 negative expertises for registration of medical devices in 2014. It was also stated that after new amendments to registration rules came into force in July, the number of positive outcomes has been rising rapidly, more than tripling, and the quantity of negative outcomes for last two months consisted of 7%.
But…here are the three most important news items I would like to highlight:
- Eurasian Economic Union – ratification is completed.
The Treaty on the Eurasian Economic Union signed by Russia, Kazakhstan and Belarus on 29th May 2014 was ratified by all countries of the Union. Russia officially ratified the document on the 3rd of October, Belarus on the 9th of October and Kazakhstan on the 14th of October. It should be reiterated that the document will come into force on the 1st January 2015 and defines, amongst others, common rules for circulation and registration of medical devices and one registration certificate valid throughout the whole EAU territory from January 2016. Current “local” registration certificates will be valid within a transition period until 31st December 2021 and will require re-registration according to the new EAU procedure before this deadline.
- First edition of the list of implantable medical devices is expected on the 18th of November.
Strict deadlines (the 6th of October) to submit the dossier for official lists “subject to state reimbursement programmes for implantable medical devices” caused a bustle in the medical device industry at the beginning of the month. Over several days 829 dossiers have been submitted from 72 applicants including manufacturers, distributors, clinical centres and professional associations. The Russian MoH promised to publish the first version of the list after the first Commission session on the 18th of November and also confirmed deadlines for submission for next year`s edition of the list as March 2015.
- Federal Law on Medical Devices – the text is available for discussion.
The text of the draft of the Federal Law on Circulation on Medical Devices became available and became the subject of discussion and critiques on different levels. The current version of the draft describes the powers of federal bodies and stipulates the regulation of medical devices’ circulation throughout their entire life cycle including importation, registration, advertisement, distribution, safety monitoring etc. The draft is available in Russian here.