In an apparent effort to increase access to China’s huge medical device market by foreign device manufacturers, the China Food and Drug Administration (CFDA) has reportedly proposed exempting a number of medium- and high-risk medical devices, as well as in-vitro diagnostic (IVD) devices from the agency’s clinical trial requirements.
According to a recent report by the Emergo Group, the proposed exemptions would apply to 48 different Class II and Class III medical device product names. The action follows a separate action earlier this year that would exempt 22 Class II devices and six Class III devices from clinical trials, and is in addition to more than 400 Class II and Class III devices already exempt from clinical trial requirements.
The report also notes that CFDA registrants who qualify for exemptions from clinical trials will be permitted to submit clinical data obtained from outside China for the purposes of filing a market application with the regulator.
Read the Emergo Group’s report on the CFDA’s proposal to exempt certain devices from clinical device requirements. The report includes links to the original Chinese language version of the CFDA’s proposal.