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| Announcement of the National Medical Products Administration on Further Strengthening Supervision and Administration of Entrusted Production by Medical Device Registrants | | 国家药监局关于进一步加强医疗器械注册人委托生产监督管理的公告 |
| (Announcement No. 38 [2024] of the National Medical Products Administration) | | （国家药监局公告2024年第38号） |
| For the purposes of implementing the Regulation on the Supervision and Administration of Medical Devices, fully implementing the primary responsibility of medical device registrants (hereinafter referred to as “registrants”) for quality and safety, further strengthening the supervision and administration of entrusted production by registrants, and effectively preventing and controlling the quality and safety risks of medical devices, relevant matters are hereby announced as follows: | | 为贯彻实施《医疗器械监督管理条例》，全面落实医疗器械注册人（以下简称注册人）质量安全主体责任，进一步加强注册人委托生产监督管理，有效防控医疗器械质量安全风险。现就有关事宜公告如下： |
| I. Strictly implementing the primary responsibility of medical device registrants | | 一、严格落实医疗器械注册人主体责任 |
| 1. A registrant shall fully implement the primary responsibility for the quality and safety of medical devices, establish a quality management system covering the whole life cycle of medical devices and maintain effective operation. A registrant entrusting production shall establish and improve a management institution that is compatible with the characteristics of the products whose production is entrusted and the enterprise scale, fully perform functions such as product risk management, change control, product release, after-sales service, handling of product complaints, adverse event monitoring and product recall, and review the operation of the quality management system of the entrusted manufacturer in accordance with the quality management specifications for production of medical devices. | | （一）注册人应当全面落实医疗器械质量安全主体责任，建立覆盖医疗器械全生命周期的质量管理体系并保持有效运行。注册人委托生产的，应当建立健全与所委托生产的产品特点、企业规模相适应的管理机构，充分履行产品风险管理、变更控制、产品放行、售后服务、产品投诉处理、不良事件监测和产品召回等职责，定期按照医疗器械生产质量管理规范对受托生产企业质量管理体系运行情况进行审核。 |
| When a registrant only entrusts production, it shall also maintain the quality management ability of the product throughout the life cycle and maintain the integrity and effectiveness of the quality management system; set up a management institution suitable for the entrusted production, and specify the responsibilities of relevant departments such as technology, production, quality management, adverse event monitoring, and after-sales service. The quality management department shall be set up independently, appoint a sufficient number of capable full-time quality management personnel and technical personnel familiar with the products and with corresponding professional knowledge, and be able to effectively monitor and control entrusted production activities. | | 注册人仅委托生产时，也应当保持产品全生命周期质量管理能力，维持质量管理体系完整性和有效性；设置与委托生产相适应的管理机构，并至少明确技术、生产、质量管理、不良事件监测、售后服务等相关部门职责，质量管理部门应当独立设置，配备足够数量和能力的专职质量管理人员，以及熟悉产品、具有相应专业知识的技术人员，能够对委托生产活动进行有效的监测和控制。 |
| A registrant shall be able to assume the responsibility for the quality and safety of medical devices in accordance with the law, and encourage the establishment of liability compensation capabilities matching factors such as the degree of product risk, market size and personal injury compensation standards through purchase of commercial insurance. | | 注册人应当能够依法承担医疗器械质量安全责任，鼓励通过购买商业保险等形式，建立与产品风险程度、市场规模和人身损害赔偿标准等因素相匹配的责任赔偿能力。 |
| 2. A registrant shall preferentially select enterprises with relatively high quality management level, relatively large production scale, good credit record, and relatively high production automation level and information management level as the trustee. Before entrusting production, a registrant shall require a trustee to submit a statement of credit status, and consult the public information on the regulatory department to fully understand the credit status of the trustee. | | （二）注册人应当优先选择质量管理水平较高、生产规模较大、信用记录良好、生产自动化程度和信息化管理水平较高的企业作为受托方。进行委托生产前，注册人应当要求受托方提交信用情况说明，并查阅监管部门公开信息，全面了解受托方信用情况。 |
| 3. Where a registrant is encouraged to produce implantable medical devices by themselves and entrusted production is really necessary, during the period of entrusted production activities, a registrant shall, in principle, select personnel with production quality management experience in relevant fields and familiar with product production process and quality control requirements to settle in the entrusted manufacturer, and provide on-site guidance for and implement supervision over key links of production management and quality management to ensure that production is organized according to laws, regulations, normative documents, mandatory standards and technical requirements for registered products. The job responsibilities of personnel appointed shall be clearly specified in the quality agreement. The products in the List of Medical Devices Prohibited from Being Produced upon Entrustment shall not be produced upon entrustment. | | （三）对于植入性医疗器械，鼓励注册人自行生产，确需进行委托生产的，在委托生产活动期间，注册人原则上应当选派具有相关领域生产质量管理工作经验、熟悉产品生产过程和质量控制要求的人员入驻受托生产企业，对生产管理、质量管理关键环节进行现场指导和监督，确保按照法规、规章、规范性文件、强制性标准和经注册的产品技术要求组织生产。派驻人员工作职责应当在质量协议中予以明确。《禁止委托生产医疗器械目录》中的产品不得委托生产。 |
| 4. A registrant entrusting production shall enter into a quality agreement with the entrusted manufacturer in accordance with the requirements of the Guidelines for the Preparation of Quality Agreement for Entrusted Production of Medical Devices and in light of the actual circumstances of the enterprise. In principle, the validity period of a quality agreement shall not exceed the validity period of the product registration certificate and the production license of the entrusted manufacturer. Under the premise of satisfying the requirements of relevant laws and regulations, a registrant may agree with the entrusted manufacturer in the quality agreement on the specific implementation method of document control, procurement control, process control, inspection control, product release, change control, etc., but must clearly conduct communication and connection with the requirements. | | （四）注册人进行委托生产，应当按照《医疗器械委托生产质量协议编制指南》要求，结合企业实际情况，与受托生产企业签订质量协议，原则上质量协议有效期限不超过产品注册证和受托生产企业生产许可证有效期限。在符合相关法规要求的前提下，注册人可以与受托生产企业在质量协议中自行约定文件控制、采购控制、过程控制、检验控制、产品放行、变更控制等的具体实施方式，但必须明确沟通和衔接要求。 |
| 5. A registrant shall, in conjunction with the entrusted manufacturer, convert the relevant requirements of the quality agreement into the management documents related to executable entrusted production, and supervise the implementation of the entrusted manufacturer. Enterprises shall be encouraged to use controlled information systems to optimize management processes related to entrusted production and improve the quality management efficiency. | | （五）注册人应当会同受托生产企业，将质量协议相关要求转化为可执行的委托生产相关管理文件，并监督受托生产企业落实到位。鼓励企业采用受控的信息化系统优化委托生产相关管理流程，提升质量管理效能。 |
| A registrant and an entrusted manufacturer shall annually review the suitability, adequacy and effectiveness of the quality agreement and confirm that the relevant requirements of the quality agreement are consistent with the entrusted production management documents and the actual production situation. Where any inconsistency is found, rectification measures shall be taken in a timely manner. | | 注册人和受托生产企业应当每年对质量协议的适宜性、充分性、有效性开展评审，确认质量协议相关要求与委托生产管理文件和实际生产情况相一致。发现不一致的，应当及时采取整改措施。 |
| 6. A registrant shall, in conjunction with the entrusted manufacturer, determine the management methods of the purchased articles and suppliers according to the degree of impact of the purchased articles on the products. For key procurement articles or main raw materials, such as raw materials of animal origin, outsourced sterilization process, key components and parts/parts/modules of active products, antigens and antibodies of in vitro diagnostic reagents, etc. purchased by an entrusted manufacturer, the registrant shall determine the procurement acceptance criteria and review the relevant suppliers by itself or in conjunction with the entrusted manufacturer. | | （六）注册人应当会同受托生产企业，根据采购物品对产品的影响程度，确定采购物品和供应商的管理方式。对于关键采购物品或者主要原材料，如动物源性原材料、外包的灭菌过程、有源产品的关键元器件/部件/组件、体外诊断试剂的抗原和抗体等，由受托生产企业进行采购的，注册人应当自行或者会同受托生产企业确定采购验收标准、对相关供应商进行审核。 |
| 7. Where the products produced upon entrustment share the production site or production equipment with other products (including different varieties, specifications, models, etc.), the entrusted manufacturer shall establish a corresponding management system under the principles of product quality risk management, risk control measures and overall balance of revenue, to prevent possible product or material confusion, cross-contamination, misuse of process parameters and other risks. | | （七）受托生产的产品与其他产品（含不同品种、规格、型号等）共用生产场地或者生产设备的，受托生产企业应当基于产品质量风险管理、风险控制措施和收益整体平衡等原则，建立相应管理制度，防止可能发生的产品或者物料混淆、交叉污染、工艺参数误用等风险。注册人应当加强对受托生产企业的监督和指导，确保相关风险控制措施落实到位。 |
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