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:
- 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 6th 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.
- 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 9th 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.
- 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.