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