How to Strengthen the Quality Supervision of the Epidemic Prevention and Control Medical Device

The implementation of the medical device registrant system is an important measure to promote the reform of the medical device review and approval system and strengthen the management of the entire life cycle of medical device. With the implementation of the "Regulations on the Supervision and Administration of Medical Device" (State Council Order No. 739), the registered system is fully implemented, and the form of medical device production organizations is more diverse, especially for medical device registrars across provinces, autonomous regions, and municipalities. Referred to as "cross -regional commissioned production"), involving the division of responsibilities and coordination of the provincial pharmaceutical regulatory department, which brings new challenges to regulatory work. In order to effectively strengthen the production supervision of medical device registered people across regions, consolidate the quality management responsibility of the registered medical device's whole life cycle, strengthen the coordination of regulatory departments, and ensure the quality and safety of medical equipment, and now put forward the following opinions.

1. Overall requirements

Drug supervision and management departments at all levels must fully implement the "Regulations on the Supervision and Administration of Medical Device" and their supporting rules and regulations, fully understand the significance of implementing the medical device registrar system, and supervise the registrar in the development, production, operation, and use of traditional Chinese medicine. The safety and effectiveness of the instrument shall bear responsibility in accordance with the law according to law; the provincial drug supervision and management department shall effectively fulfill the supervision responsibilities, strengthen cross -regional collaborative supervision, form a supervisory working mechanism with clear responsibilities, smooth information, orderly connection, and strong collaboration, and promote medical equipment The high -quality development of the industry ensures the safety and effectiveness of the people's use of weapons.

2. Implement supervision responsibilities and strengthen supervision and inspection

(1) Strengthen the verification of the quality system of the registration applicant. Those who entrust the production of product registration across regions, the medical device registrar applicant's local province, autonomous region, and municipality's drug supervision and management department is responsible for conducting the verification of the registered quality system, and cooperates with the drug supervision and management department of the provinces, autonomous regions, and municipalities of the entrusted production enterprise (hereinafter Referred to as "the provincial bureau of the entrusted production enterprise"), joint or commissioned to conduct on -site inspections, and the provincial bureau of the trustees of the trustee shall support cooperation. The drug supervision and management departments of the registered applicants are located in the provinces, autonomous regions, and municipalities directly under the Central Government. Based on the verification, the verification conclusions are proposed and a system verification report is issued. The system verification report shall include the inspection of the quality system of the registrant and the trustee and the trustee, and copy it to the provincial bureau where the trustee is located.

(2) Strengthen the supervision and inspection of production links. The registered provinces, autonomous regions, and municipalities of the cities (hereinafter referred to as the "Provincial Bureau where the registrar is located") shall implement supervision responsibilities, and conduct daily supervision and inspection of registered production activities in accordance with the hierarchical supervision regulations, monitoring, random inspections, and inspection inspections, and inspections, and inspections, and inspections, and inspection inspections, and inspection inspections, and inspection inspections, and inspections. Complaints and reports have been carried out for inspection. The provincial bureau where the entrusted production enterprise is located is responsible for conducting daily supervision and inspection of the production activities of the trustee production enterprises, and cooperates with the provincial bureau where the registrant is located to conduct joint inspections or commissioned inspections on the entrusted production enterprise.

(3) Strengthen the results of inspection results. If the provincial bureau where the registrar is located, the relevant issues involved in the entrusted production enterprise in the supervision and inspection of the registrar, shall notify the provincial bureau where the trustee is located to jointly or entrust the provincial bureau of the trustee to conduct inspections; If an enterprise is suspected of violations of laws and regulations, it shall notify the provincial bureaus where the trustee is located, and the provincial bureau of the trustees' production enterprise is investigated and disposed of in accordance with the law. Essence

3. Clarify responsibility and obligations and strengthen the monitoring of random inspection

(4) Strengthen the quality sampling of medical equipment. The provincial bureau where the registrant of the medical device is located is responsible for organizing the quality sampling inspection of the production link of the registrar of the medical device, and may entrust the provincial bureau of the entrusted enterprise to sample. If the requirements for quality random inspections do not meet the requirements of the regulations and meet the requirements of the case, the provincial bureau where the medical device registrar is located will be investigated and dealt with, and the inspection conclusions and the case shall be copied to the local situation where the trustee is located. When the quality announcement was issued, the trustees were announced. The provincial bureau where the registrar is located shall urge the registrant to thoroughly find the reasons for unqualified and rectify the rectification; if the entrusted production enterprise fails to organize the production in accordance with the requirements of the regulations, the provincial bureau where the registrar is located shall promptly notify the provincial bureau of the trustee. The bureau conducted investigation and disposal according to law.

(5) Strengthen the monitoring of bad events in the registrant. The provincial bureau of the medical device registrar must urge the registrant to effectively perform the main responsibility of the monitoring of bad events in medical device. Medical device registrars shall be based on the "Regulations on the Supervision and Administration of Medical Device", "Medical Device Adverse Incident Monitoring and Re -Evaluation Management Measures" and relevant guide documents. The requirements for the establishment of a bad event monitoring system, actively collecting, reporting, investigating, and evaluating the bad events of the product, timely discover and control the unreasonable risks of the existence of the product to ensure the safety and effectiveness of the listing products.