Therapeutic equipment company's business scope of the specific content based on the company's actual business content and determine, generally include the following: a class of medical devices, Class II medical device wholesale, retail, Class III medical device business (see the license for the specific project), engaged in the field of medical science and technology technology consulting, technological development, technical services, technology transfer, own Equipment leasing (shall not engage in financial leasing), mechanical equipment (except special equipment) installation, maintenance, health consulting (shall not engage in diagnostic and therapeutic activities, psychological counseling) and so on.
Legal Objective:"Supervision and Administration of Medical Devices" Article 3
The State Food and Drug Administration is responsible for the supervision and administration of the national medical device business. 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.