Notice for Imported Class III Medical Devices Applied as Class II Devices
On June 5, 2020, CMDE released a notice about the application withdrawal and re-application process for the imported Class III medical devices that were initially registered as Class II devices in China. Recently, CMDE found many imported medical devices were applied to be registered as Class II medical devices while they are identified as Class III devices after review. In that case, the device registration application shall be withdrawn and reapply the registration as class III. The specific withdrawing and reapplying process are elaborated in this notice and it is noteworthy that an extra fee will be required given the change of medical device classification.
