Russia Medical Device Market Access, ISO 13485, and CE Marking for Medical Device Manufacturers

The Russian medical device market is one of the largest for exporters. With over 140,000,000 people, Russia is a lucrative market for medical device companies. In recent years, the Russian medical device regulators have worked to decrease ambiguity in its regulations and create clarity for medical device manufacturers to import their products. However, the intricacies of its regulation and the lack of information in English seem to keep medical device manufactures from reaping the benefits of the Russian market.

Join LNE/G-MED and Alexey Stepanov, Regulatory and Quality Assurance Manager Russia and CIS at Sorin Group to have a clear view on the Russian medical device registration process, as well as how to leverage your current product submissions to make your Russian application less labor-intensive.

In this webinar, medical device manufacturers will learn about:

The Russian medical device registration regulations,
ISO 13485’s role in the Russian medical device registration regulations, and
How a manufacturer with CE marking can re-use parts of their CE marking submission for their Russian medical device registration.
If you’re a device manufacturer in Russia, the steps for CE marking.