Written by ForeignExchange Translations on Thursday, February 07, 2013
The changes are fairly comprehensive. MassDevice has a good overview. Here are the high points:
- Registration certificates need to include different information
- Device manufacturers must now designate an Authorized Representative
- Additional testing requirements for measuring medical devices
- "Expertise Centers" will determine whether or not registrants must conduct clinical trials in Russia
The changes will contribute to a clearer, less vague regulatory environment in Russia. However, as Emergo Group says, medical device registration in Russia still remains a complex endeavor.
[Tip of the hat to MassDevice!]
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