The specific content of the business scope of the medical device company is based on the actual business content of the company to determine, generally includes 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:"Regulations on the Supervision and Administration of Medical Devices"
Article 4
The state implements classified management of medical devices in accordance with the degree of risk. The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices. The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Evaluation of the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, use and other factors.