2. It has a relatively independent business place suitable for its business scale and scope;
3. Having storage conditions suitable for the business scale and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;
4, should establish and improve the product quality management system, including procurement, incoming inspection, warehousing, outbound audit, quality tracking system and adverse event reporting system;
5, should have the technical training and after-sales service ability to adapt to the medical device products, or agree to provide technical support by a third party.
6. To apply for the Medical Device Business License, it must pass the inspection and acceptance by the (food) drug supervision and administration department.
7. The business scope specified in the Medical Device Business License shall be determined according to the management category and category code specified in the Medical Device Classification Catalogue.
Legal basis: Regulations of People's Republic of China (PRC) on the Supervision and Administration of Medical Devices.
Article 4 The local people's governments at or above the county level shall strengthen their leadership over the supervision and management of medical devices within their respective administrative areas, organize and coordinate the supervision and management of medical devices and emergency response within their respective administrative areas, strengthen the capacity building of medical device supervision and management, and provide guarantee for the safety of medical devices.
The pharmaceutical supervisory and administrative departments of local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within the scope of their respective duties.
Article 5 The supervision and management of medical devices shall follow the principles of risk management, overall control, scientific supervision and social co-governance.
Article 6 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.
The drug supervision and administration department of the State Council is responsible for formulating the classification rules and catalogues of medical devices, analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification rules and catalogues. To formulate and adjust the classification rules and classification catalogue, we should fully listen to the opinions of medical device registrants, filers, production and operation enterprises, users and industry organizations, and refer to international medical device classification practices. The classification rules and catalogue of medical devices shall be announced to the public.