Product categories are as follows:
Class I – Medical devices with lower risks; their safety and effectiveness can be guaranteed by implementing general management
Class II – Medical devices with moderate risk; their safety and effectiveness can be guaranteed by implementing stricter management
Class III – Medical devices with higher risks; their safety and effectiveness can be guaranteed by taking special measures and by stricter management
NOTE: Class I medical devices require record-filing by municipal NMPA. Class II and III require provincial and state NMPA registration, respectively.