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:

1. 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.

2. First edition of the list of implantable medical devices is expected on the 18th of November.
   Strict deadlines (the 6^th 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.

3. 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.

September saw the introduction of regulatory initiatives which sometimes provoked new questions. Two main aspects of the development of medical device regulations include work on Eurasian medical device guidelines (for which there was no noticeable progress last month) and new legal acts for Russia:

1. List of implantable medical device reimbursement

Published Order #698, which defines the rules for grouping implantable medical devices in official lists subject to state reimbursement programmes, was the subject of much debate within the Russian medical device industry in September. For future state reimbursement programmes of gratuitous medical treatment system a medical device must be included in this list by a special MoH commission which follows a thirty day procedure. The list should be in line with medical device classification and consist of medical devices registered in Russia based on clinical safety data/justification additionally requested by the commission. The order imposed very strict deadlines for application for inclusion on the current list (as of the 6^th of October 2014), but there is not yet a clear list of documents required for submission, the MoH commission still doesn’t exist and the new medical device classifications described in the procedure is far from clear.

2. New list of medical devices subject to 10% VAT

From the beginning of 2013, new Russian medical device regulations caused confusion over the applicability of VAT for medical device importation. This was largely due to differences in terminology between these guidelines and the Russian tax code. Changes in the Russian tax code in November 2013 made the situation clearer, but the positions of different Russian localities on providing preferential VAT rates for importation remained ambiguous. Government Resolution #870 came into force on the 9^th of September 2014, thereby clarifying terminology and confirming the list of medical devices subject to 10% VAT during importation in Russia. Hopefully this will put an end to the lack of clarity for this group of medical products. A government order with a similar list of medical devices subject to 0% VAT is expected within the next few months.

3. Federal law on circulation of medical devices

The Russian Ministry of Health published a notice about the development of a federal law on circulation of medical devices. The draft of the law is intended to ensure quality, safety and efficacy at every stage of the medical device lifecycle. It is commonly known that this type of unified legal framework is currently missing in Russia, resulting in a number of contradictions between the various regulatory acts in the medical device domain. The MoH announced the target date for this law as January 2016. The text of the current version of the document is currently officially unavailable, and as such it is still unclear how this law will accord with further medical device regulation of Eurasian customs union.