China-More Exemptions for Medical Devices and IVDs
On September 30, 2018, China’s National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA), has expanded for the second time in 2018, its list of medical devices and IVDs that are exempt from local clinical trial requirements.
The new addition of 84 medical devices and 277 IVDs brings up the total list of exempted products to 855 medical devices and 393 IVDs.
The new list includes several types of moderate- and high-risk medical devices and IVDs. These exemptions demonstrate NMPA’s ongoing efforts to loosen Chinese market entry restrictions for foreign medical device and IVDs manufacturers.