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The QMN Weekly Bulletin

CFDA Exempts Some Class II Devices From Clinical Trials, Beefs Up Inspections

Nov. 29, 2013
The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data. Registration submissions for exempted products should include a detailed comparison of the device and a predicate device that is already on the market.
International Medical Device Regulatory Monitor