DOCUMENT REQUIREMENTS
If a medical device company wants to register a device that is not manufactured in China, it is required that the company provide device samples to the NMPA for testing.
In the case of registering Class II and Class III devices, manufacturers are obligated to submit the appropriate documents showing that the device has been approved in its country of origin (i.e. CE Mark, 510(k) letter, ISO 13485 certification, approved Premarket Approval Application). It may also be required to provide supportive clinical data along with the application. All product information on packaging and labeling must be translated to Simplified Chinese.
Foreign manufacturers must also hire China-based agents that will represent their interests in China. The responsibilities of the designated agents include providing technical service and maintenance support for the device, assisting with device recall (if recall is required), overseeing the registration process, and providing support for the manufacturer in case adverse events occur due to device malfunction.