Masterarbeit

Registration procedure for medical devices in the Russian Federation – under consideration of the new EEU regulations

Tanja Hanikel (2016)

Summary
Language: English
In this thesis the Russian market for medical devices, its challenges during the registration procedure and the registration procedure in detail are discussed. Company’s should carefully evaluate the risk and uncertainties of pursuing registration in the Russian market, as the Russian regulatory process remains unpredictable and suffers from a lack of clear guidance. Therefore the duration of registration procedure can have an open end and the costs of the registration and certification remain unanswered question. Further challenges and changes are expected in 2016. Russian government is already planning new changes on medical device registration procedure in 2016. Also new changes are coming with the enforcement of the new harmonized regulations for EEU.
To handle the bad health care situation Russia has to import goods. Around two thirds of the medical device market is supplied by imports from Germany, the USA and Japan. Among the most imported medical device products are diagnostic imaging devices, neurosurgery, cardio-surgery and telemedicine devices (USA Trade, 2012) (Emergo, 2015b).
The newest trend and a consequence of the current economic sanctions from the European Union, Russia decided to concentrate the production of medical devices in-country. Foreign manufacturers must comply with Russian device regulations and registration requirements, such as in-country testing, clinical trials, etc. regardless of their medical device class, international testing already completes, or international approvals, such as CE marking or 510(k) clearance. The current system is also very much unclear and is based on previous regulation, which is suffering from a lack of transparency.
To obtain access to the Russian Federation, medical device manufacturers will have to undergo a challenging registration process. According to Roszdravnadzor, the Russian health-care agency, new regulations for medical devices have been implemented in the country on January 1st, 2013. According to decree no. 1416, the official review process includes two stages of the review.
Russian Duma ratified the Agreement on common principles and rules of circulation of medical devices within the Eurasian Economic Union (EEU).This agreement implies the harmonization of registration and labelling requirements, circulation, and post-market surveillance for medical devices across Russia, Belarus, and Kazakhstan from the 1st January 2016. The Russian federation is working together with Belarus, Kazakhstan and Armenia, to develop regulations that will cover the territory of the Eurasian Union. It is impossible to predict how the final situation will look like.
In the end, for a successful submission procedure in Russia it is not enough to have a complete and clear documentation. The manufacturer needs to understand and respect the Russian culture, mentality and habits. To get the certificate manufacturers have to follow some unwritten rules.
Pages: 59
Annexes: 04, Pages 34