Draft Chinese FDA Medical Device Classification Catalogue would Reduce Number of Device Groups
EMERGO SUMMARY OF KEY POINTS:
- The Chinese FDA’s new draft classification catalogue would reduce the number of device groups from 43 to 22.
- More than 4,000 new examples of which devices fall under which CFDA classification categories would be included in the new catalogue.
The China Food and Drug Administration (CFDA), which oversees China’s medical device market, has published a draft version of its new medical device classification catalogue for public comment.
According to an Emergo analysis of the draft catalogue (link in Chinese), devices in the new version of the document are divided into groups based mainly on function and clinical application considerations; in the current catalog, device groups are determined based on multiple criteria. As such, the draft version of the catalogue would reduce the total number of device groups from 43 to 22.
Under the draft catalogue’s 22 new device groups, the CFDA has proposed 205 primary device categories and 1,136 secondary device categories. Regulators have also increased the number of examples of devices that fall under these categories—the current catalogue provides 1,008 examples, whereas the draft version provides 5,461.
Finally, the CFDA has included a proposal in the draft catalogue to down-classify 19 device types, but it remains unclear which devices would be affected by the proposal. Emergo will continue monitoring the issue and inform current and prospective Chinese market registrants of any new details as we learn them.
For additional information on medical device registration in China, download our regulatory process chart.