The China Food and Drug Administration (CFDA) is taking steps to strengthen the innovation of medical devices and its approval system. To carry out this goal, medical device clinical assessment and exemptions need to be standardized and extended, respectively. The CFDA published a draft document that contains new Class II and III medical and IVD devices exempt from clinical trials.
There are now a total of four batches of medical devices that have been exempted, the first three to be found in this catalogue. The medium and high risk devices that make up the fourth group included in this draft are arteriovenous lancets, aneurysm clips, anesthesia needles and incubators. ‚ There are also Class II and III IVDs included in the draft that may be exempt from clinical trials in the future.