MEDICAL DEVICE REGISTRATION AND REGULATORY APPROVAL PROCESSES IN RUSSIA

Medical device manufacturers looking to sell products in Russian markets are required to demonstrate compliance to Russian medical device regulations: the Law 323 of the Russian Federation, Decree on medical device registration rules #1416 and the pertinent Customs Union Technical Regulations (CU-TR). Obtaining regulatory approval is especially challenging due to ongoing legislative revisions, which creates ambiguity, in addition to navigating Russian bureaucracy and language barriers. Manufacturers must also be prepared to test their devices during this process as the region’s systems continues to rely on product testing, regardless of whether the device has already been approved elsewhere.

• Reviewing main laws and regulations affecting medical device registration procedure and the role of the main official bodies involved in the process: Roszdravnadzor, expert bodies, test labs, etc.
• Russian regulators’ approach to the definitions of medical devices and accessories and their classifications in Russia.
• Overview of the registration process and potential registration pitfalls, timelines, and costs.
• Requirements for testing of medical devices for registration.
• Closer look of requirements for technical file for medical device registration in Russia.
• Status of Eurasian medical device harmonization initiative. How will it affect medical device approval process in 2016?

Speaker:
Alexey Stepanov
Regulatory and Quality Assurance Manager Russia and CIS
Sorin Group