The specific business scope of a medical device company is determined according to the actual business content of the company, which generally includes the following contents: wholesale and retail of Class I and Class II medical devices, operation of Class III medical devices (see the license for specific items), technical consultation, technical development, technical service and technology transfer in the field of medical science and technology, lease of self-owned equipment (financing lease is not allowed), installation, maintenance and sanitation of mechanical equipment (except special equipment).
Legal objectivity:
Regulations on the supervision and administration of medical devices
Article 4
The state implements classified management of medical devices according to the degree of risk. The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management. The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness. The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness. To evaluate the risk degree of medical devices, the expected use, structural characteristics and use methods of medical devices should be considered.