In January 2013, Russia implemented its current device law, Resolution 1416. The Russian market offers substantial opportunity for medical device and IVD manufacturers. However, the regulatory system continues to challenge companies with its lack of transparency and complex regulatory structure. In this white paper we discuss the changing regulatory landscape, the challenges facing manufacturers who wish to enter Russia, and changes expected to be introduced.
In this white paper:
- Undefined aspects of the Russian regulations
- Clinical trial/testing requirements
- Overview of the regulatory structure
- Classifying products in Russia
- Steps to registration
- Declaration of Conformity Certification in Russia, and how it differs from the EU
- Updating registrations
- Expected legislation
About the Author:
Christine Hall is the Manager, International Operations at Emergo.