CFDA Exempted 140 Class II Devices from Clinical Trial

China Food and Drug Administration (CFDA) issued notice exempting 140 Class II medical devices from submitting clinical trial when device producers apply for market entry from CFDA. This is already the second batch of clinical trial exemption.

For a Class II device maker outside China, perhaps JV with a local Chinese producer is one the best options if one looks for a long term reward in the Chinese market, depending on the nature of the product itself.