Opinions of the General Department of the State Food and Drug Administration on Strengthening the Collaborative Supervision of Cross-regional Commissioned Production of Medical Devices


Release time:

2022-04-11

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 whole life cycle of medical devices. With the implementation of the regulations on the Supervision and Administration of Medical Devices (decree No. 739 of the State Council), the registrant system has been fully implemented, and the organizational forms of medical device production have become more diverse. in particular, medical device registrants carry out entrusted production across provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as "cross-regional entrusted production"), involving the division of responsibilities and coordination of provincial drug regulatory departments, bringing new challenges to the regulatory work. In order to effectively strengthen the supervision of cross-regional entrusted production by medical device registrants, consolidate the note.

Opinions of the General Department of the State Food and Drug Administration on Strengthening the Collaborative Supervision of Cross-regional Commissioned Production of Medical Devices

 

All provinces, autonomous regions, municipalities directly under the Central Government and the Drug Administration of Xinjiang Production and Construction Corps:

 

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 whole life cycle of medical devices. With the implementation of the regulations on the Supervision and Administration of Medical Devices (decree No. 739 of the State Council), the registrant system has been fully implemented, and the organizational forms of medical device production have become more diverse. in particular, medical device registrants carry out entrusted production across provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as "cross-regional entrusted production"), involving the division of responsibilities and coordination of provincial drug regulatory departments, bringing new challenges to the regulatory work. In order to effectively strengthen the cross-regional entrusted production supervision of medical device registrants, consolidate the quality management responsibility of the registrant's medical device life cycle, strengthen the coordination of regulatory departments, and ensure the quality and safety of medical devices, the following opinions are hereby put forward.

 

General 1. requirements

 

Drug supervision and administration departments at all levels should fully implement the Regulations on the Supervision and Administration of Medical Devices and its supporting rules and regulations, fully understand the significance of implementing the medical device registrant system, and supervise registrants to take responsibility for the safety and effectiveness of medical devices in the whole process of development, production, operation and use in accordance with the law. Provincial drug supervision and administration departments should earnestly fulfill their regulatory responsibilities and strengthen cross-regional coordinated supervision, we will form a regulatory working mechanism with clear responsibilities, smooth information, orderly convergence and strong cooperation, promote the high-quality development of the medical device industry, and ensure the safe and effective use of equipment by the people.

 

2. implementation of regulatory responsibilities, strengthen supervision and inspection
 

(I) strengthen the registration applicant quality system verification. Where cross-regional entrusted production applies for product registration, the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the medical device registrant is located shall be responsible for the verification of the registration quality system, and cooperate with the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the entrusted production enterprise is located (hereinafter Referred to as the "provincial bureau where the entrusted production enterprise is located"), jointly or commissioned shall carry out on-site inspections. The drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant is located shall, according to the verification situation, put forward the verification conclusion and issue the system verification report. The system verification report shall contain the inspection of the quality system of the registered person and the entrusted production enterprise, and shall be copied to the provincial bureau where the entrusted production enterprise is located.

 

If it is approved for listing, the entrusted production address shall be published in the production address column of the medical device registration certificate and marked with "(entrusted production)", and the name of the entrusted production enterprise shall be noted in the remarks column. The production of entrusted medical devices shall not be entrusted again, and the time limit for handling relevant work shall be strictly implemented in accordance with relevant regulations.

 

(II) strengthen the supervision and inspection of production links. The drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the registrant is located (hereinafter referred to as the "provincial bureau where the registrant is located") shall implement regulatory responsibilities, carry out daily supervision and inspection of the registrant's production activities in accordance with hierarchical supervision regulations, and conduct monitoring of adverse events, spot checks, and complaints. The provincial bureau where the entrusted production enterprise is located shall be responsible for carrying out daily supervision and inspection of the production activities of the entrusted production enterprise, and shall cooperate with the provincial bureau where the registrant is located to carry out joint inspection or entrusted inspection of the entrusted production enterprise.

 

The whole project inspection of the registrant shall include the inspection of the corresponding entrusted production activities of the entrusted production enterprise. The provincial bureau where the registrant is located may, on its own or in conjunction with the provincial bureau where the entrusted production enterprise is located, carry out cross-regional inspection of the entrusted production enterprise, and if it is difficult to carry out cross-regional inspection due to objective factors, the entrusted inspection may be carried out after consultation with the consent of the provincial bureau where the entrusted production enterprise is located. For emergency investigation and handling of emergencies, if the provincial bureau where the registrant is located cannot immediately send inspectors due to objective factors, it shall promptly entrust the provincial bureau where the entrusted production enterprise is located to carry out the inspection, and the provincial bureau where the entrusted production enterprise is located shall provide regulatory support and actively undertake the inspection tasks entrusted by the provincial bureau where the registrant is located.

 

If the provincial bureau where the registrant is located conducts its own inspection of the entrusted production enterprise, it shall communicate with the provincial bureau where the entrusted production enterprise is located in advance, and the provincial bureau where the entrusted production enterprise is located shall send observers to assist in the relevant work, and the inspection report shall be copied to the provincial bureau where the entrusted production enterprise is located. In case of joint inspection, the inspection team leader shall in principle be the inspector of the provincial bureau where the registrant is located, the provincial bureau where the entrusted production enterprise is located shall carry out the inspection in accordance with the plan agreed by both parties, and feedback the inspection results to the provincial bureau where the registrant is located within 10 working days after the inspection.

 

(III) strengthen the disposal of inspection results. If the provincial bureau where the registrant is located finds that the relevant problems involve the entrusted production enterprise during the supervision and inspection of the registrant, it shall notify the provincial bureau where the entrusted production enterprise is located, and jointly or entrust the provincial bureau where the entrusted production enterprise is located to conduct the inspection; if the entrusted production enterprise is found to have any suspected violations of laws and regulations, it shall notify the provincial bureau where the entrusted production enterprise is located, and the provincial bureau where the entrusted production enterprise is located shall investigate and dispose of the disposal according to complete, in principle, the provincial bureau where the registrant is located shall be notified of the disposal within 10 working days.

 

In addition, if during the verification of the registered quality system, it is found that the entrusted production enterprise that has obtained the production license has other suspected violations of laws and regulations, the provincial bureau where the entrusted production enterprise is located shall be responsible for the disposal. After the disposal is completed, in principle, the disposal shall be reported to the provincial bureau where the registered applicant is located within 10 working days.

 

3. clarify responsibilities and obligations, strengthen sampling monitoring

 

(IV) strengthen the quality of medical equipment sampling work. The provincial bureau where the medical device registrant is located is responsible for organizing the quality sampling inspection of the production process of the medical device registrant, and may entrust the provincial bureau where the entrusted enterprise is located to sample. If the quality sampling inspection finds that it does not meet the prescribed requirements and meets the conditions for filing a case, the provincial bureau where the medical device registrant is located shall investigate and deal with the case of the registrant, and promptly copy the inspection conclusion and the filing situation to the bureau where the entrusted enterprise is located. When the quality announcement is issued, the entrusted production enterprise shall be announced together.

 

The provincial bureau where the registrant is located shall urge the registrant to thoroughly find out the reasons for the disqualification and make effective rectification in place; if the entrusted production enterprise fails to organize production in accordance with the requirements of laws and regulations, the provincial bureau where the registrant is located shall promptly notify the provincial bureau where the entrusted enterprise is located, and the provincial bureau where the entrusted enterprise is located shall investigate and dispose of it in accordance with the law.

 

(V) strengthen the monitoring of adverse events of registrants. The provincial bureau where the medical device registrant is located shall urge the registrant to earnestly fulfill the main responsibility of monitoring adverse events of medical devices. The medical device registrant shall establish an adverse event monitoring system according to the requirements of the Regulations on Supervision and Administration of Medical Devices, the Administrative Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices and relevant guide documents, actively collect, report, investigate and evaluate adverse events of products, and timely discover and control unreasonable risks of products, ensure the safety and effectiveness of products on the market.

 

If the adverse event is reported to the provincial bureau of the place where the product is suspected of having significant quality and safety risks, it shall promptly notify the provincial bureau where the registrant is located. The provincial bureau where the registrant is located shall conduct an investigation and evaluation, and if the investigation involves a cross-regional entrusted production situation, the provincial bureau where the entrusted enterprise is located shall cooperate. If it is confirmed that there are significant quality and safety risks in the relevant products, the provincial bureau where the registrant is located shall supervise the registrant to take risk control measures, and inform the provincial bureau where the entrusted enterprise is located of the investigation and evaluation conclusion and the risk control measures taken by the registrant, and the provincial bureau where the entrusted enterprise is located shall investigate and dispose of the entrusted production enterprise in accordance with the law.

 

4. improve the collaborative regulatory system, the formation of regulatory synergy

 

(VI) strengthen regulatory coordination. On the basis of strict implementation of responsibilities, all provincial bureaus should strengthen information communication and supervision coordination, establish a smooth cooperative supervision mechanism, form an effective supervision closed loop, and ensure that the whole life cycle and whole chain supervision of medical devices are "seamless" and "no dead ends". Encourage the establishment of a normalized cross-regional regulatory working group among provincial bureaus, study and issue detailed regulatory guidance documents, explore and improve the cross-regional collaborative regulatory mechanism for medical devices, encourage centralized training and experience exchange of inspectors across administrative regions, unify inspection standards, clarify inspection requirements, and improve inspection efficiency.

 

(VII) strengthen the interconnection of regulatory information. Drug supervision and administration departments should continue to strengthen information construction, improve the level of intelligent supervision, take the initiative to collect registration and supervision information, establish and continuously update the credit files of registrants and entrusted production enterprises, timely, complete and accurate data exchange with the data sharing platform of the State Administration, so as to realize the collaborative sharing of data throughout the system. The State Food and Drug Administration is responsible for continuously improving the functions of the medical device production supervision information platform, strengthening random inspection and adverse event data update, and realizing multi-dimensional query and statistical analysis; all provincial bureaus should effectively strengthen the use and docking of the medical device production supervision information platform, and strengthen the data exchange and collaborative supervision under the medical device registrant system.

 

(VIII) seriously investigate and deal with violations of laws and regulations. If suspected violations of medical device laws and regulations are found, they should be investigated and dealt with in accordance with the principles of territorial supervision and in accordance with the provisions of the "Regulations on the Supervision and Administration of Medical Devices", implement the penalties for illegal acts to the requirements of individuals, and strengthen the connection of execution and discipline. For cases involving registrants and entrusted production enterprises at the same time, the relevant provincial bureaus shall strengthen cooperation in investigation, organize and carry out case clue notification, investigation and evidence collection, inspection and testing, and jointly crack down on illegal acts; major cases and typical cases investigated and handled shall be reported in a timely manner, and the State Food and Drug Administration shall be responsible for selecting typical cases to be notified, thus forming a sharp sword and high deterrent effect.

 

If the first-class medical device filer and the entrusted manufacturer are not in the same city divided into districts, supervision and management shall be carried out with reference to this opinion.