1, with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles;
2, with the scale and scope of operation of relatively independent premises;
3, with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of medical equipment products;
4, should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
5, should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.
6, the application for "Medical Device Business License" must pass the inspection and acceptance of the (food) drug supervision and management department.
7, "Medical Device Business License" listed in the business scope should be in accordance with the medical device classification directory specified in the management category, class code name.
Expanded
Enterprises should establish a quality management system covering the whole process of medical device business, and keep relevant records or files, including the following:
1, quality management organization or quality management personnel responsibilities;
2, quality management regulations;
3, procurement, receipt, acceptance provisions (including procurement records, acceptance records, accompanying goods, etc.);
4, supplier qualification audit provisions (including suppliers and product legitimacy audit of the relevant documents, etc.);
5, warehouse storage, storage management provisions (including temperature records, records of storage, regular inspection records, records of the warehouse, etc.);
6, sales and after-sales service regulations (including salesperson authorization, purchaser files, sales records, etc.);
7, substandard medical device management regulations (including destruction records, etc.);
8, medical device return, replacement regulations;
9, medical device adverse event monitoring and reporting regulations (including stopping the operation of the notification records, etc.);
10, medical device recall regulations (including medical device recall records, etc.);
11, facility and equipment maintenance and verification and calibration regulations (including facility and equipment related records and files, etc.);
12, health and personnel health status regulations (including employee health records, etc.);
13, quality management training and assessment regulations (including training records, etc.);
14, medical device quality complaints, accident investigation and handling of reports (including quality complaints, accident investigation and handling of reports corresponding to the records and files, etc.).
Baidu Encyclopedia - Medical Device Business Quality Management Standard
Baidu Encyclopedia - Medical Device Business License