There are three scenarios for the key inspection contents when medical device manufacturers carry out supervision and inspection:
For medical device registrants and filers who produce by themselves:
1. The implementation of laws and regulations, medical device production quality management regulations by medical device registrants and record holders;
2. Organize production in accordance with mandatory standards and registered and filed product technical requirements, and the consistency between actual production and medical device registration and filing, medical device production license filing, etc.;
3. The continuous compliance and effectiveness of the operation of the quality management system;
4. The legal representative, the person in charge of the enterprise, the manager’s representative and other personnel are familiar with the relevant laws and regulations of medical devices;
5. The performance of the manager’s representative;
6. Changes in the legal representative, person in charge of the enterprise, management representative, quality inspection agency or full-time personnel, production site, environmental conditions, key production inspection equipment, etc.;
7. Corrective and preventive measures for problems found in user feedback and internal audits;
8. The implementation of the rectification of the problems found in the company’s product sampling inspection, supervision and inspection, complaints and reports;
9. Internal audit, management review, change control, annual self-examination report, etc.;
10. Other items that should be checked in particular.
For medical device registrants and filers who adopt the entrusted production method:
1. The implementation of laws and regulations, medical device production quality management regulations by medical device registrants and record holders;
2. Whether the operation of the quality management system is continuously compliant and effective;
3. The performance of the manager’s representative;
4. Organize production in accordance with mandatory standards and product technical requirements that have been registered or filed;
5. Corrective and preventive measures for problems found in user feedback and internal audits;
6. Internal audit, management review, change control, annual self-examination report, etc.;
7. Carry out adverse event monitoring, re-evaluation, product safety risk information collection and evaluation, etc.;
8. Listing and release of products;
9. The supervision of the entrusted production enterprise, the performance of the entrusted production quality agreement, the design conversion and change control of the entrusted production products, the production release of the entrusted production products, etc.;
10. Other items that should be checked in particular.
When necessary, inspections may be carried out on the entrusted production enterprises.
For entrusted production enterprises:
1. Consistency between actual production and medical device registration and filing, medical device production license filing, etc.;
2. Entrusted production enterprises to implement laws and regulations, medical device production quality management standards;
3. The legal representative, the person in charge of the enterprise, the manager’s representative and other personnel are familiar with the relevant laws and regulations of medical devices;
4. Changes in the legal representative, person in charge of the enterprise, management representative, quality inspection agency or full-time personnel, production site, environmental conditions, key production inspection equipment, etc.;
5. Production and release of products;
6. The implementation of the rectification of problems found in the company’s product sampling inspection, supervision and inspection, complaints and reports;
7. Internal audit, management review, annual self-examination report, etc.;
8. Other items that should be checked in particular.
When necessary, inspections can be carried out on medical device registrants and filers.
In summary, the drug regulatory department implements hierarchical management and dynamic adjustments to medical device registrants, record holders, and entrusted manufacturers based on the risk levels of products and companies, and combines the production quality management and business conditions of each company, medical device adverse events, Product complaints and reports and corporate credit status are comprehensively judged, and hierarchical supervision and management are implemented.