The third class medical device business license business scope mainly includes 6804 ophthalmic surgical instruments; 6807 thoracic cardiovascular surgical instruments; 6810 orthopaedic surgery (orthopaedic) surgical instruments; 6815 injection and puncture instruments; 6821 medical electronic instrumentation and equipment; 6822 medical optical instruments, instruments and endoscopic equipment; 6822 -1 Medical Optical Apparatus, Instruments and Endoscopic Equipment, etc.
Legal Objective:Measures for the Supervision and Administration of Medical Devices Business, Article 3
The State Food and Drug Administration is responsible for the supervision and administration of medical devices business nationwide. Food and drug supervision and management departments at or above the county level are responsible for the supervision and management of medical device business in the administrative area.
The higher-level food and drug supervision and management departments are responsible for guiding and supervising the lower-level food and drug supervision and management departments to carry out supervision and management of medical devices.
Article 4
In accordance with the degree of risk of medical devices, medical device business implementation of classification management.
The operation of Class I medical devices do not require licensing and filing, the operation of Class II medical devices for the record management, the operation of Class III medical devices license management.