China NMPA registration

China's National Medical Products Administration (NMPA) classifies products into Class I, Class II and Class III medical devices according to the risk level of medical devices. Among them, the class I medical devices shall implement filing management, and the class II and class III medical devices shall implement registration management. Class II and Class III medical devices shall pass the quality management system verification of the drug regulatory department before obtaining the product registration certificate, and different product types such as sterile medical devices, implanted medical devices, in vitro diagnostic reagents, customized dentures and independent software shall be implemented in accordance with the corresponding appendix of the corresponding "Medical Device Manufacturing Quality Management Practice". The Medical Device Registration Certificate is valid for 5 years.

Medical device import registration (including Class I II and III medical devices) should be submitted to the State Drug Administration registration application, at the same time need to submit the registration applicant's country (region) authorities to allow the medical device marketing documents. The Medical Device Registration Certificate is valid for 5 years.