Taking into account beginning of the summer “low season” for official organizations, there were no major “sharp” changes in Russian Medical Device Regulations in June but there are still some important strategic points to be aware of:
1. Timelines for the harmonization of medical device market in the Customs Union have been defined.
The Treaty on the Eurasian Economic Union was signed by Russia, Kazakhstan and Belarus in Astana on 29th May 2014 and will come into force on 1st January 2015.The document is based on the principles of common economic space, which were harmonized by the rules of the World Trade Organization. Articles 31 and 100 of the document suggest the gradual formation of a common market for medical products, with harmonized regulations, standards and unified requirements for the efficiency, safety and quality of medical devices in the entire Customs Union territory. The specific deadline for the beginning of a common market of medical devices was established as 1st January 2016.
2. Russian MoH is working on new medical device classification.
It is well known that with the implementation of new rules for medical devices in early 2013, the existing classification of medical devices raised a lot of misunderstandings and practical questions. The key message from Roszdravnadzor (the Russian approval agency), transmitted in June 2014, is harmonization of new medical device classification with GMDN (global medical device nomenclature). The new national classification is expected to contain about 22,000 items structured by a 6-digit code built on the GMDN approach. The code is expected to be placed in the registration certificate and be valid throughout all of Russia’s territory. The draft of the new regulations is expected to be available for public discussion in the coming months.
3. Russian medical device industry anticipates amendments to simplify current registration procedure.
At the end of May 2014, Roszdravnadzor confirmed upcoming amendments of existing procedures for registration of medical devices. The main highlights in the prepared initiative are:
A. “Stopwatch” rule – the possibility to voluntarily suspend the procedure up to 50 days after the first phase of expertize to resolve faults in the dossier or to re-submit additional or missing documents without getting an official refusal.
B. Non-sterile medical devices of first safety class without measurement functions will pass through a simplified registration with a reduced expertize phase.
C. For renewal of expiring registration certificates, a simplified procedure will be implemented instead of a full registration cycle, which is de jure required now according to current rules.