China medical device QA/RA blog

News and commentary on regulatory changes.

In Brief: New Medical Device Regulation Published in China

Emergo’s local office reports that the Chinese government has published a new Medical Device Supervision Management Regulation (link in Chinese) covering the country’s medical device regulatory system.

The new regulation will go into force June 1, 2014.

Emergo is currently studying the new document to determine its impact on medical device manufacturers selling in the Chinese market. We will provide further analysis in the next issue of RADAR.

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