The Russian regulatory environment remains in a state of flux since the release of Decree 1416 in January 2013. Almost three years have passed since the implementation of the new device law, yet some areas of the regulatory process remain undefined. 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 Authors:
Mara Salisbury is a Global Regulatory Research Associate, and Christine Hall is Business Development Manager.