Medical Device Business License Category III Business Scope

Legal analysis: the business scope of three types of registered medical device companies:

Sales of medical instruments: medical electronic instruments and equipment, medical optical instruments, instruments and endoscope equipment, medical magnetic vibration equipment, medical X-ray equipment, operating room, emergency room and outpatient equipment and appliances; Category: clinical laboratory analytical instruments. Sales of computer software and auxiliary equipment, electronic products, stationery, handicrafts (excluding cultural relics), building materials, mechanical equipment, furniture, instruments and meters; Economic and trade consultation.

Retail injection puncture instruments, medical polymer materials and products, clinical inspection and analysis instruments, in-vitro diagnostic reagents, medical electronic instruments and equipment, disinfection and sterilization equipment and appliances.

Legal basis: Measures for the Supervision and Administration of Medical Device Operation

Article 3 The China Food and Drug Administration shall be responsible for the supervision and administration of the operation of medical devices nationwide. The food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of the operation of medical devices within their respective administrative areas. The food and drug supervision and administration department at the higher level is responsible for guiding and supervising the food and drug supervision and administration department at the lower level to carry out the supervision and administration of medical device operation.

Article 4 Medical devices shall be classified and managed according to their risk degree. There is no need for licensing and filing for operating Class I medical devices, filing management for operating Class II medical devices and licensing management for operating Class III medical devices.