National Medical Products Administration (NMPA) is in charge of all pharmaceuticals and medical device regulations in China.
Medical devices are being classified into 3 classes. All according to their potential risks. Class I (Lowest), Class II (Middle) & Class III (Highest).
A further breakdown in the specifics of the 3 classes;
Class I – All devices in which safety and effectiveness can be assured through routine administration.
Class II – All devices involving further controls and monitoring in order to ensure safety and effectiveness.
Class III –All devices used for life support or sustenance, which might be a potential threat to health or relating to any implants into the human body.
If a medical device not manufactured in China wants to be registered in the Chinese market, device samples are required to be sent to NMPA for testing.
All product information on both packaging and labeling must be translated to Simplified Chinese.
The Medical device registration validity is 5 years. If a renewal should be required, the application should be submitted 6 months in advance before the expiry date.
Foreign manufacturers and brands must hire China-based agents to represent their brand in the Chinese market.