The new 2014 edition of China’s medical device regulations brought about several changes to the registration process for medical devices in China. Notably, Class I devices now only require filing rather than registration. However, the registration cycle has been extended, especially for Class III devices. More documents are now required, including documents regarding product development and risk management.
More Class II and Class III devices are required to do clinical trials, but the CFDA now also provides a clinical trial exemption list for some Class II and Class III medical devices. For high risk Class III devices, the trial protocol will have to be submitted for CFDA approval prior to starting clinical trials.
An on-site QMS audit may be requested after the registration application is submitted. In addition, the time limit for submitting supplementary materials has been extended from 60 days to 1 year.