Announcement of the National Medical Products Administration on Further Strengthening the Supervision and Management of Production Commissioned by Medical Device Registered Persons (No. 38 of 2024)
In order to implement the Regulations on the Supervision and Administration of Medical Devices, fully implement the quality and safety main responsibility of the registrant of medical devices (hereinafter referred to as the registrant), further strengthen the production supervision and management entrusted by the registrant, and effectively prevent and control the quality and safety risks of medical devices. The relevant matters are hereby announced as follows:
One、 Strictly implement the main responsibility of medical device registrants
（1） The registrant shall fully implement the main responsibility for the quality and safety of medical devices, establish a quality management system covering the entire life cycle of medical devices, and maintain effective operation. If the registrant entrusts production, it shall establish and improve a management organization that is suitable for the characteristics of the entrusted products and the scale of the enterprise, fully fulfill the responsibilities of product risk management, change control, product release, after-sales service, product complaint handling, adverse event monitoring, and product recall, and regularly audit the operation of the entrusted production enterprise's quality management system in accordance with the medical device production quality management standards.
When the registrant only entrusts production, they should also maintain the ability to manage the quality of the entire product lifecycle, and maintain the integrity and effectiveness of the quality management system; Establish a management organization that is suitable for commissioned production, and at least clarify the responsibilities of relevant departments such as technology, production, quality management, adverse event monitoring, and after-sales service. The quality management department should be independently established, equipped with sufficient numbers and capabilities of full-time quality management personnel, as well as technical personnel familiar with the product and possessing corresponding professional knowledge, who can effectively monitor and control commissioned production activities.
The registrant should be able to legally assume responsibility for the quality and safety of medical devices, and encourage the establishment of liability compensation capabilities that match factors such as product risk level, market size, and personal injury compensation standards through the purchase of commercial insurance and other forms.
（2） The registrant shall give priority to selecting enterprises with high quality management level, large production scale, good credit record, high level of production automation and information management as the trustee. Before entrusting production, the registrant shall require the entrusted party to submit a credit statement and review publicly available information from regulatory authorities to fully understand the entrusted party's credit situation.
（3） For implantable medical devices, registrants are encouraged to produce them themselves. If commissioned production is necessary, during the commissioned production activities, registrants should, in principle, select personnel with relevant experience in production quality management, familiar with product production processes and quality control requirements to settle in the commissioned production enterprise, provide on-site guidance and supervision of key links in production management and quality management, and ensure that production is organized in accordance with regulations, rules, normative documents, mandatory standards, and registered product technical requirements. The job responsibilities of dispatched personnel should be clearly defined in the quality agreement. Products listed in the Catalogue of Prohibited Commissioned Production of Medical Devices shall not be commissioned for production.
（4） The registrant shall sign a quality agreement with the entrusted production enterprise in accordance with the requirements of the "Guidelines for the Preparation of Quality Agreements for Medical Device Commissioned Production" and based on the actual situation of the enterprise. In principle, the validity period of the quality agreement shall not exceed the validity period of the product registration certificate and the production license of the entrusted production enterprise. Subject to compliance with relevant regulations, the registrant may agree on specific implementation methods for document control, procurement control, process control, inspection control, product release, change control, etc. with the entrusted production enterprise in the quality agreement, but communication and connection requirements must be clearly defined.
（5） The registrant shall, in conjunction with the entrusted production enterprise, translate the relevant requirements of the quality agreement into executable management documents related to entrusted production, and supervise the entrusted production enterprise to implement them properly. Encourage enterprises to adopt controlled information systems to optimize the management processes related to commissioned production and improve quality management efficiency.
The registrant and the entrusted production enterprise shall conduct an annual review of the suitability, adequacy, and effectiveness of the quality agreement to confirm that the relevant requirements of the quality agreement are consistent with the entrusted production management documents and the actual production situation. If inconsistencies are found, corrective measures should be taken promptly.
（6） The registrant shall, in conjunction with the entrusted production enterprise, determine the management methods for the purchased goods and suppliers based on the degree of impact of the purchased goods on the products. For key procurement items or main raw materials, such as animal derived raw materials, outsourced sterilization processes, key components/parts/assemblies of active products, antigens and antibodies of in vitro diagnostic reagents, etc., which are purchased by entrusted production enterprises, the registrant shall determine the procurement acceptance standards and conduct audits of relevant suppliers on their own or in conjunction with the entrusted production enterprises.
（7） If the entrusted production of products shares the production site or equipment with other products (including different varieties, specifications, models, etc.), the entrusted production enterprise shall establish corresponding management systems based on the principles of product quality risk management, risk control measures, and overall profit balance, to prevent potential risks such as product or material confusion, cross contamination, and misuse of process parameters. The registrant shall strengthen supervision and guidance over the entrusted production enterprises to ensure that relevant risk control measures are implemented effectively.
（8） When the registrant entrusts production, they shall establish a product release procedure, clarify the release standards and conditions, review the production process records, quality inspection results, and release documents of the entrusted production enterprise for medical devices. Those that meet the standards and conditions can only be listed after being signed by authorized release personnel. The release of products for listing shall be completed by the registrant themselves and shall not be entrusted to other enterprises for listing release.
The entrusted production enterprise shall establish a production release procedure, clarify the standards and conditions for production release, audit the production process of medical devices, inspect the products, and confirm that they meet the standards and conditions before production release.
The record retention period for product release and production release shall comply with the relevant requirements of the Medical Device Production Quality Management Standards.
（9） The registrant shall, in conjunction with the entrusted production enterprise, clarify the communication mechanism for corrective and preventive measures, responsibilities of both parties, and disposal requirements in the quality agreement, and develop corrective and preventive control procedures that are appropriate for product risks. When there is a significant decrease in product quality compliance, consecutive batches of intermediate or finished products that are not qualified, or risk events in post market risk management that exceed acceptable criteria, the registrant should investigate and analyze the discovered problems together with the entrusted production enterprise, develop and review corrective and preventive action plans, implement relevant measures, and evaluate the effectiveness of the measures.
（10） The registrant shall strengthen its ability to control changes, establish a sound change control procedure in conjunction with the entrusted production enterprise, and conduct change evaluation, verification, or confirmation. For the introduction or change of outsourcing suppliers such as commissioned research and development, production process outsourcing, and service outsourcing, risk assessment should be conducted to determine whether the relevant changes affect the effective operation of the quality management system, and change control should be implemented.
（11） The registrant of commissioned production shall, in accordance with the "Management Measures for Monitoring and Re evaluation of Adverse Events of Medical Devices" and other regulations, and based on the characteristics of product risks, allocate sufficient resources, improve mechanisms, strengthen capabilities in institutional system construction, personnel allocation, information collection and reporting, event investigation and disposal, risk research and evaluation, and effectively assume the responsibility of monitoring adverse events of medical devices. The responsibilities and obligations of both parties in the investigation and disposal of adverse events shall be stipulated in the quality agreement. The adverse event monitoring responsibility that the registrant should fulfill as stipulated in regulations such as the Regulations on the Supervision and Administration of Medical Devices shall not be transferred to the entrusted production enterprise through quality agreements.
Two、 Effectively strengthen the management of entrusted production and registration of medical devices
（12） If the registrant (applicant) entrusts production, the relevant processes of entrusted production of the entrusted production enterprise shall be clearly included in the scope of the registrant's quality management system in the quality management system documents, and the procedures and related materials for the consignor to measure, analyze, and improve the entrusted party shall be covered in the "Quality Management System Documents - Measurement, Analysis, and Improvement Procedures of Quality Management System" submitted in the registration application.
When conducting the verification of the registered quality management system, special attention should be paid to the establishment of the enterprise's quality management organization, the allocation and performance of key personnel in the quality system, the signing of quality agreements, and the management of commissioned research and production. For cross regional commissioned production within the country, the verification of the registration quality management system should, in principle, be carried out by the drug supervision and administration department of the place where the registrant (applicant) is located, or jointly with the drug supervision and administration department of the place where the entrusted production enterprise is located, to conduct a comprehensive inspection of the operation of the quality management system of the registrant (applicant) and the entrusted production enterprise. In special circumstances, if the drug supervision and administration department where the registrant (applicant) is located is unable to send inspectors, the drug supervision and administration department where the entrusted production enterprise is located may be entrusted to verify the entrusted production enterprise. The drug supervision and administration department where the registrant (applicant) is located shall review and confirm the verification report of the entrusted production enterprise based on the registration (applicant)'s human body verification situation.
（13） For registration or renewal applications involving domestic commissioned production, the registration approval department shall record the commissioned production address in the production address column of the medical device registration certificate and indicate "(commissioned production)". At the same time, the name of the commissioned production enterprise and the unified social credit code shall be noted in the remarks column in the form of "commissioned production enterprise: XXXX company; Unified Social Credit Code: XXXX. If the registration change involves the registrant entrusting production, the relevant information of entrusted production should also be indicated in the registration change document in the above manner, and the change information should be updated in the corresponding fields of the production address and remarks on the registration certificate, and submitted in accordance with the data collection requirements of the National Drug Regulatory Data Sharing Platform. The provincial drug regulatory department where the registrant and the entrusted production enterprise are located shall promptly record the relevant information of the entrusted production in the enterprise credit file.
If there is only a textual change in the name of the entrusted production enterprise, there is no need to apply for change registration. When renewing the registration, a modified registration certificate will be issued.
Each provincial drug regulatory department shall organize a review of the registration certificates for commissioned production issued within its administrative region. If it is found that the relevant information has not been marked in accordance with the above requirements, it shall urge the registrant to apply for marking to the original registration department in a timely manner and complete the marking within 3 months from the date of implementation of this announcement.
（14） If the production address of domestic medical devices changes and the production scope of the entrusted production enterprise can cover the entrusted production varieties without involving changes in the production license, an explanation issued by the drug supervision and administration department of the place where the entrusted production enterprise is located should be submitted when handling the registration certificate change filing.
If the registrant no longer engages in entrusted production, they shall promptly reduce the entrusted production address to the original registration department; The entrusted production enterprise shall promptly report relevant information to the provincial drug supervision and administration department where it is located.
Three、 Continuously strengthen the supervision and management of commissioned production
（15） Provincial drug supervision and administration departments should effectively implement their local regulatory responsibilities, comprehensively sort out and grasp the background of various types of registrants and entrusted production enterprises within their administrative regions through various methods and channels such as collecting information on entrusted production registration certificates, supervising enterprises to report production varieties, and receiving cross regional production variety notifications, and strengthen supervision in a targeted manner in accordance with risk management principles.
The provincial drug regulatory department where the registrant is located shall continue to pay attention to the registrant's ability to manage the quality of medical devices throughout their entire life cycle, evaluate and control the entrusted production enterprises, and manage changes, and verify the information provided by the registrant based on the inspection results of the entrusted production enterprises. The provincial drug supervision and administration department where the entrusted production enterprise is located shall continuously pay attention to the production and quality management of the entrusted production products, urge the entrusted production enterprise to carry out production activities in accordance with laws, regulations, normative documents, mandatory standards, registered product technical requirements, and entrusted production quality agreements.
（16） If the registrant switches from self production to commissioned production, or changes the entrusted production enterprise, they shall promptly report to the provincial drug supervision and administration department where the registrant is located. The provincial drug regulatory department where the registrant is located shall conduct a comprehensive inspection of the quality management system of the registrant and the entrusted production enterprise. The inspection of the entrusted production enterprise may be conducted in conjunction with the provincial drug regulatory department where the entrusted production enterprise is located.
（17） Drug regulatory authorities at all levels should deeply recognize the complexity and particularity of production supervision entrusted by registrants, scientifically allocate regulatory resources, and enrich regulatory means.
In areas where the number of registered persons for entrusted production is relatively concentrated, provincial drug supervision and management departments should regularly hold special consultations on the supervision of the registered persons' entrusted production, analyze the results of supervision and inspection and product sampling, comprehensively investigate the safety hazards in the enterprise's quality management system and product quality, take targeted prevention and control measures, and eliminate systematic and regional risks.
Encourage drug supervision and management departments to explore synchronous supervision and inspection at two locations, namely the registrant and the entrusted production enterprise, by connecting to the inspection site through remote network and other information technology means, to communicate inspection information in a timely manner and unify inspection standards.
（18） The National Medical Products Administration continues to promote the construction of medical device variety archives and credit archives, and promotes the interconnection and intercommunication of information related to production entrusted by registrants by standardizing the labeling of production information on registration certificates; Provincial drug regulatory authorities should achieve full chain information connectivity for medical device supervision within their administrative regions, gather information on review and approval, registration quality management system verification, production licensing, supervision and inspection, enterprise reporting, supervision and sampling, and illegal behavior investigation, continuously update and improve the credit files of registrants and entrusted production enterprises, and push them to the national drug regulatory data sharing platform as required by the National Medical Products Administration, gradually achieving cross provincial regulatory information exchange.
For cross regional commissioned production, the provincial drug regulatory department where the registrant and the commissioned production enterprise are located shall, in accordance with the requirements of the "Measures for the Supervision and Administration of Medical Device Production" and the "Opinions on Strengthening the Collaborative Supervision of Cross regional Commissioned Production of Medical Devices", promptly report regulatory information such as enterprise production varieties, inspection results, and responsibility interviews.
（19） If it is found during supervision and inspection that the quality management system of the registrant or entrusted production enterprise has not been effectively operated, the provincial drug regulatory department shall order them to rectify within a specified period of time; If the registrant and the entrusted production enterprise fail to take effective measures to eliminate the existing quality and safety risks, the provincial drug regulatory department shall promptly take measures such as warnings and responsibility interviews. If necessary, the registrant and the entrusted production enterprise may conduct joint responsibility interviews with the provincial drug regulatory department where they are located.
If the registrant or entrusted manufacturing enterprise seriously violates the quality management standards for medical device production, and after comprehensive analysis, it is believed that it affects product safety, effectiveness, and may harm human health, the provincial drug supervision and administration department may take emergency control measures to suspend production, operation, and use, and strictly impose penalties in accordance with Article 86 of the Regulations on the Supervision and Administration of Medical Devices.
（20） This announcement shall come into effect on June 1, 2024.
Article source: National Medical Products Administration
Original link:https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20240403170020128.html
