Medical Translation Insight

The Russian Ministry of Health has put in place new rules regarding medical device classification, importation, and adverse event handling. The revised regulations took effect January 1, 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

(For the official resolution, see the Russian and Google Translate'd English version.)

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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