China Adds to its Catalogue of Medical Devices and IVD Products Exempt from Clinical Trials

More than two dozen medical devices with documented track records of safety are now exempt from the clinical trials previously required of the Chinese authorities, saving manufacturers of the devices the expense of conducting the costly trials in order to be approved for the Chinese market.

China’s National Medical Products Administration (NMPA) released its revised list of exemptions in January. Newly exempt devices include metal locking bone plates and bone screws, breast tissue markers, mobile C-arm X-ray machines, venous blood reservoirs, and some in vitro device (IVD) reagents. The exemptions represent the sixth time China’s National Medical Products Administration (NMPA) has revised its Catalog of Medical Devices and IVD Products Exempted from Clinical Trials since the list was first established in 2014. The list includes more than 1,000 medical devices and more than 400 IVDs considered safe because their design is well established, they have no record of serious adverse events, and ample data from clinical trials conducted elsewhere that demonstrates their safety and efficacy.