Management of medical equipment

1. The state implements a medical device registration and filing management system. (1) Product filing management is implemented for Class I medical devices. Category II and III medical devices shall be subject to product registration management. For the declaration of Class I medical devices, clinical trials are not required. To apply for the registration of Class II and Class III medical devices, clinical trials shall be conducted. For the record-keeping of Class I medical devices in China, the record-keeping materials shall be submitted to the municipal food and drug supervision and administration department with districts.

Category II medical devices in China are examined by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and after approval, medical device registration certificates are issued. Class III medical devices in China are reviewed by China Food and Drug Administration, and medical device registration certificates are issued after approval. For the record-keeping of imported medical devices of Class I, the record-keeping person shall submit the record-keeping materials to China Food and Drug Administration. The import of Class II and Class III medical devices shall be examined by the State Food and Drug Administration, and a medical device registration certificate shall be issued after approval.

(two) the establishment of a class of medical device production enterprises, by the municipal food and drug supervision and management departments for production record, issued a class of medical device production record certificate. The establishment of Class II and Class III medical device manufacturing enterprises shall be examined and approved by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government.