Medical device license knowledge training content is as follows:
Medical device management
1. The state of medical devices to implement the registration, filing management system. (1) Class I medical devices to implement product record management. Class II and Class III medical devices to implement product registration management. For the first class of medical devices for the record, do not need to conduct clinical trials. Apply for Class II and Class III medical device registration, clinical trials should be conducted. The filing of Class I medical devices within the territory shall be submitted to the municipal food and drug supervision and management department of the district for filing information.
The second class of medical devices within the territory of the provincial, autonomous regions and municipalities directly under the Central Food and Drug Administration for examination, approval and issue of medical device registration certificate. Domestic Class III medical devices by the State Food and Drug Administration review, approval issued after the medical device registration certificate. Import of Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Import of Class II and Class III medical devices by the State Food and Drug Administration for review and approval of the medical device registration certificate issued.
(2) the opening of the first class of medical device manufacturers, by the municipal food and drug supervision and management department for the production of the record, and issued a class of medical devices production record vouchers. The opening of the second class, the third class of medical device manufacturers, by the location of the provincial, autonomous regions, municipalities directly under the Central Food and Drug Administration for examination and approval.