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：
一、严格落实医疗器械注册人主体责任
（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。
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。
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。
（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。
（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。
（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。
（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。
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。
（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。
（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。
（八）注册人委托生产时，应当建立产品上市放行规程，明确放行标准、条件，对医疗器械生产过程记录、质量检验结果和受托生产企业生产放行文件进行审核，符合标准和条件的，经授权的放行人员签字后方可上市。产品上市放行应当由注册人自行完成，不得委托其他企业上市放行。
受托生产企业应当建立生产放行规程，明确生产放行的标准、条件，对医疗器械生产过程进行审核，对产品进行检验，确认符合标准、条件的，方可生产放行。
产品上市放行、生产放行的记录保存期限，应当符合医疗器械生产质量管理规范相关要求。
（九）注册人应当会同受托生产企业，在质量协议中明确纠正预防措施沟通机制、双方职责和处置要求，并制定与产品风险相适宜的纠正预防控制程序。出现产品质量符合性有显著降低趋势，连续多批次中间品或者成品不合格，上市后风险管理中的风险事件超出可接受准则等趋势性、系统性、突发性问题时，注册人应当与受托生产企业共同对发现的问题进行调查和分析，制定并评审纠正预防措施计划，实施相关措施并对措施的有效性进行评价。
（十）注册人应当强化变更控制能力，会同受托生产企业，建立完善的变更控制程序，做好变更评估、验证或者确认。对于委托研发、生产过程外包和服务外包等外包供方的引入或者变更，应当通过风险评估判定相关变化是否影响质量管理体系有效运行，做好变更控制。
（十一）委托生产的注册人应当按照《医疗器械不良事件监测和再评价管理办法》等规定，结合产品风险特点，在制度体系建设、机构人员配备、信息收集上报、事件调查处置、风险研究评价等方面，配足资源、完善机制、强化能力，切实承担医疗器械不良事件监测责任，并在质量协议中约定在不良事件调查处置中委托双方的责任义务。对于《医疗器械监督管理条例》等法规规定的注册人应当履行的不良事件监测责任，不得通过质量协议向受托生产企业转移。
二、切实强化医疗器械委托生产注册管理
（十二）注册（申请）人委托生产的，应当在质量管理体系文件中明确将受托生产企业的委托生产相关过程纳入注册人质量管理体系覆盖范围，并在注册申报提交的“质量管理体系文件—质量管理体系的测量、分析和改进程序”中涵盖委托方对受托方进行测量、分析和改进的程序及相关资料。
开展注册质量管理体系核查时，应当重点关注企业质量管理机构建立情况，质量体系关键人员配备和在职履职情况，质量协议签订情况，委托研发和委托生产管理情况等内容。涉及境内跨区域委托生产的，注册质量管理体系核查原则上应当由注册（申请）人所在地药品监督管理部门自行或者联合受托生产企业所在地药品监督管理部门，对注册（申请）人及受托生产企业质量管理体系运行情况进行全面检查。特殊情况下注册（申请）人所在地药品监督管理部门确实无法派出检查人员的，可以委托受托生产企业所在地药品监督管理部门对受托生产企业进行核查，注册（申请）人所在地药品监督管理部门应当结合注册（申请）人体系核查情况对受托生产企业核查报告进行审核确认。
（十三）涉及境内委托生产的注册申请或者延续注册申请，注册审批部门应当在医疗器械注册证生产地址栏中登载受托生产地址并注明“（委托生产）”，同时在备注栏备注受托生产企业名称和统一社会信用代码，备注形式为“受托生产企业：XXXX公司；统一社会信用代码：XXXX”。变更注册涉及注册人委托生产的，也应当在变更注册文件中按照上述方式注明委托生产相关信息，并将变更信息在注册证书生产地址和备注相应字段中更新，按照国家药品监管数据共享平台数据采集要求报送。注册人、受托生产企业所在地省级药品监督管理部门应当及时将委托生产相关信息记录在企业信用档案中。
仅受托生产企业名称文字性变化的，无需申请变更备案，在延续注册时，核发修改后的注册证。
各省级药品监督管理部门应当组织对本行政区域内已核发的委托生产的注册证进行梳理，发现未按照上述要求标注相关信息的，应当督促注册人及时向原注册部门申请标注，并在本公告施行之日起3个月内完成标注。
（十四）境内医疗器械生产地址变更且受托生产企业生产范围可以涵盖受托生产品种，不涉及生产许可证变更的，办理注册证变更备案时应当提交受托生产企业所在地药品监督管理部门出具的说明。
注册人不再进行委托生产的，应当及时向原注册部门核减受托生产地址；受托生产企业应当及时向所在地省级药品监督管理部门报告有关情况。
三、持续加强委托生产监督管理
（十五）省级药品监督管理部门应当切实落实属地监管责任，通过收集委托生产注册证信息、督促企业上报生产品种、接收跨区域生产品种通报等多种方式和途径，全面梳理和掌握本行政区域内各类型注册人和受托生产企业底数，按照风险管理原则，有针对性加强监管。
注册人所在地省级药品监督管理部门应当持续关注注册人医疗器械全生命周期质量管理能力、对受托生产企业的评估和管控能力、变更管理能力，并结合对受托生产企业检查情况核实注册人提供的信息。受托生产企业所在地省级药品监督管理部门应当持续关注受托生产产品的生产和质量管理情况，督促受托生产企业按照法规、规章、规范性文件、强制性标准、经注册的产品技术要求和委托生产质量协议等开展生产活动。
（十六）注册人由自行生产转为委托生产，或者变更受托生产企业的，应当及时向注册人所在地省级药品监督管理部门报告。注册人所在地省级药品监督管理部门应当对注册人和受托生产企业质量管理体系进行全面检查，对受托生产企业的检查可以会同受托生产企业所在地省级药品监督管理部门进行。
（十七）各级药品监督管理部门应当深刻认识到注册人委托生产监管的复杂性和特殊性，科学配备监管资源，丰富监管手段。
委托生产注册人相对集中的地区，省级药品监督管理部门应当结合监管工作开展情况，定期对注册人委托生产监管情况进行专题会商，分析监督检查和产品抽检结果，全面排查企业质量管理体系、产品质量方面存在的安全隐患，采取针对性防控措施，杜绝系统性、区域性风险。
鼓励药品监督管理部门探索在注册人和受托生产企业两个场地同步开展监督检查，通过网络远程方式连接检查现场等信息化手段，及时沟通检查信息、统一检查尺度。
（十八）国家药监局持续推进医疗器械品种档案和信用档案建设，通过规范注册证委托生产信息标注，推动注册人委托生产相关信息互联互通；省级药品监督管理部门应当实现本行政区域内医疗器械监管全链条信息贯通，汇集审评审批、注册质量管理体系核查、生产许可、监督检查、企业报告、监督抽检、违法行为查处等信息，持续更新完善注册人、受托生产企业信用档案，并按国家药监局要求推送至国家药品监管数据共享平台，逐步实现跨省监管信息互通。
涉及跨区域委托生产的，注册人、受托生产企业所在地省级药品监督管理部门应当按照《医疗器械生产监督管理办法》《关于加强医疗器械跨区域委托生产协同监管工作的意见》要求， 及时将企业生产品种、检查结果和责任约谈等监管信息进行通报。
（十九）监督检查中发现注册人、受托生产企业质量管理体系未有效运行的，省级药品监督管理部门应当责令其限期整改；注册人、受托生产企业对存在的质量安全风险未采取有效措施消除的，省级药品监督管理部门应当及时采取告诫、责任约谈等措施，必要时，注册人和受托生产企业所在地省级药品监督管理部门可以开展联合责任约谈。
注册人、受托生产企业严重违反医疗器械生产质量管理规范，综合研判后认为影响产品安全、有效，可能危害人体健康的，省级药品监督管理部门可以采取暂停生产、经营和使用的紧急控制措施，并严格按照《医疗器械监督管理条例》第八十六条进行处罚。
（二十）本公告自2024年6月1日起施行。
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The following is an unofficial translation
Announcement of the State Food and Drug Administration on Further Strengthening the Supervision and Management of Medical Device Registrants Entrusted Production (No. 38 of 2024)
Content: In order to implement the Regulations on the Supervision and Administration of Medical Devices, fully implement the main responsibility for quality and safety of medical device registrants (hereinafter referred to as registrants), further strengthen the supervision and management of production entrusted by registrants, and effectively prevent and control the quality and safety risks of medical devices. The relevant notice is as follows:
First, 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 whole life cycle of medical devices and maintain effective operation. Where the registrant entrusts production, it shall establish and improve a management organization that is compatible with the characteristics and scale of the products it entrusts to produce, and fully perform functions such as product risk management, change control, product release, after-sales service, product complaint handling, adverse event monitoring and product recall. Regularly audit the operation of the quality management system of the entrusted production enterprise in accordance with the quality management standards of medical device production.
When the registrant only commissioned 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 organization suitable for the commissioned production, and at least clarify the responsibilities of relevant departments such as technology, production, quality management, adverse event monitoring, after-sales service, etc. The quality management department shall be set up independently, equipped with a sufficient number and ability of full-time quality management personnel, as well as technical personnel familiar with the product and with corresponding professional knowledge. Ability to effectively monitor and control commissioned production activities.
The registrant shall be able to bear 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 the purchase of commercial insurance.
(2) The registrant shall preferentially select enterprises with higher quality management level, larger production scale, good credit record, and higher production automation and information management level as the trustee. Before commissioning production, the registrant shall require the agent to submit a statement of credit status, and consult the public information of the regulatory authority to fully understand the credit status of the agent.
(3) For implantable medical devices, the registrant is encouraged to produce by itself, and if it is necessary to carry out commissioned production, during the commissioned production activities, the registrant shall, in principle, select personnel who have experience in production quality management in relevant fields and are familiar with product production process and quality control requirements to settle in the commissioned production enterprise. Provide on-site guidance and supervision for key links of production management and quality management to ensure that production is organized according to laws, regulations, normative documents, mandatory standards and registered product technical requirements. The job responsibilities of accredited personnel should be clearly defined in the quality agreement. The products in the List of Prohibited Medical Devices shall not be commissioned for production.
(4) The registrant shall sign a quality agreement with the entrusted manufacturer in accordance with the requirements of the "Guidelines for the Preparation of Quality Agreements for Entrusted Production of Medical Devices" and in combination with 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 manufacturer. On the premise of meeting the requirements of relevant laws and regulations, the registrant can agree with the entrusted production enterprise in the quality agreement on the specific implementation of document control, procurement control, process control, inspection control, product release, change control, etc., but must clearly communicate and connect the requirements.
(5) The registrant shall, together with the entrusted production enterprise, convert the relevant requirements of the quality agreement into enforceable management documents related to entrusted production, and supervise the implementation of the entrusted production enterprise. Enterprises are encouraged to use controlled information systems to optimize management processes related to commissioned production and improve quality management efficiency.
The registrant and the entrusted production enterprise 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. If any inconsistency is found, corrective measures shall be taken in a timely manner.
(6) The registrant shall, together with the entrusted production enterprise, determine the management methods of the procured goods and suppliers according to the degree of impact of the procured goods on the products. For key procurement items or main raw materials, such as raw materials of animal origin, outsourced sterilization process, key components/components/components of active products, antigens and antibodies of in vitro diagnostic reagents, etc. purchased by the entrusted manufacturer, the registrant shall determine the procurement acceptance criteria and audit the relevant suppliers by itself or jointly with the entrusted manufacturer.
(7) Where the entrusted products share the production site or production equipment with other products (including different varieties, specifications, models, etc.), the entrusted production enterprise shall establish a corresponding management system based on the principles of product quality risk management, risk control measures and overall balance of revenue, so as to prevent possible risks such as product or material confusion, cross-contamination, and misuse of process parameters. The registrant shall strengthen the supervision and guidance of the entrusted production enterprise to ensure that the relevant risk control measures are put in place.
(8) When the registrant entrusts production, it shall establish product listing release procedures, clarify release standards and conditions, review the production process records of medical devices, quality inspection results and production release documents of the entrusted manufacturer, and if the standards and conditions are met, the authorized release personnel can sign before listing. The product listing release shall be completed by the registrant itself, and shall not entrust other enterprises to list release.
The entrusted manufacturer shall establish production release procedures, clarify the standards and conditions for production release, audit the production process of medical devices, inspect the products, and confirm that the standards and conditions are met before production release.
The record keeping period of product marketing release and production release shall meet the relevant requirements of medical device production quality management norms.
(9) The registrant shall, in conjunction with the entrusted production enterprise, clarify the communication mechanism for corrective and preventive measures, the responsibilities and disposal requirements of both parties in the quality agreement, and develop corrective and preventive control procedures appropriate to product risks. When there is a trend, systemic or sudden problem such as the product quality conformity has a significant decrease trend, successive batches of intermediate products or finished products are unqualified, and risk events in post-market risk management exceed the acceptable criteria, the registrant shall jointly investigate and analyze the discovered problems with the entrusted manufacturer, and formulate and review the corrective and preventive action plan. Implement relevant measures and evaluate their effectiveness.
(10) The registrant shall strengthen the ability of change control, jointly with the entrusted production enterprise, establish a sound change control procedure, and do a good job of 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 do a good job of change control.
(11) The registrant of commissioned production shall, in accordance with the provisions of the "Medical Device Adverse Event Monitoring and Reevaluation Management Measures" and other provisions, combined with the product risk characteristics, allocate sufficient resources, improve the mechanism and strengthen the capacity in terms of system construction, institutional staffing, information collection and reporting, incident investigation and disposal, risk research and evaluation, and effectively assume the responsibility for monitoring medical device adverse events. In the quality agreement, the responsibilities and obligations of the entrusted parties in the investigation and disposal of adverse events are agreed. The adverse event monitoring responsibility that the registrant should perform as stipulated in the Regulations on the Supervision and Administration of Medical Devices and other regulations shall not be transferred to the entrusted manufacturer through the quality agreement.
Second, effectively strengthen the registration management of medical device commissioned production
(12) Where the registrant (applicant) entrusts production, the relevant processes of entrusted production shall be clearly included in the quality management system documents of the entrusted production enterprise into the coverage of the registrant's quality management system. In addition, the "Quality Management System Document-Measurement, analysis and improvement procedures of Quality management System" submitted in the registration application shall cover the procedures and related materials of the entrusting party for the measurement, analysis and improvement of the entrusted party.
When carrying out the verification of the registered quality management system, it should focus on the establishment of the quality management organization of the enterprise, the key personnel of the quality system and the performance of their duties, the signing of the quality agreement, the entrusted research and development and the entrusted production management. Involving domestic cross-regional entrusted production, the verification of the registered quality management system shall, in principle, be conducted by the drug regulatory department of the place where the registered (applicant) person is located or jointly with the drug regulatory 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 registered (applicant) person and the entrusted production enterprise. Under special circumstances, if the drug regulatory department of the place where the registrant (applicant) is located is really unable to send inspectors, it may entrust the drug regulatory department of the place where the entrusted manufacturer is located to verify the entrusted manufacturer. The drug regulatory department of the place where the registrant (applicant) is located shall examine and confirm the verification report of the entrusted manufacturing enterprise in combination with the verification of the registrant (applicant) system.
(13) For the registration application or renewal application involving domestic commissioned production, the registration examination and approval department shall record the entrusted production address and indicate "(commissioned production)" in the production address column of the medical device registration certificate, and note the name of the entrusted production enterprise and the unified social credit code in the remarks column, in the form of "entrusted production enterprise: XXXX Company; Unified social credit code: XXXX ". If the change registration involves the registrant's commissioned production, it shall also indicate the information related to the commissioned production in the change registration document in accordance with the above methods, and update the change information in the corresponding fields of the production address and remarks of the registration certificate, and submit it in accordance with the data collection requirements of the national drug regulatory data sharing platform. The registrant and the provincial drug supervision and administration department where the entrusted production enterprise is located shall promptly record the relevant information of the entrusted production in the enterprise credit file.
If the name of the production enterprise is changed in character only, there is no need to apply for the change of the record, and the revised registration certificate shall be issued when the registration is renewed.
Each provincial drug regulatory department shall organize the registration certificate of commissioned production that has been issued within the administrative region to comb, and find that the relevant information is not marked in accordance with the above requirements, shall urge the registrant to apply 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) Where the domestic medical device production address is changed and the production scope of the entrusted manufacturer can cover the entrusted production varieties and does not involve the change of the production license, the explanation issued by the drug regulatory department of the entrusted manufacturer shall be submitted when filing the change of the registration certificate.
If the registrant no longer engages in commissioned production, it shall promptly reduce the commissioned production address to the original registration department; The entrusted manufacturer shall promptly report the relevant situation to the local provincial drug regulatory department.
Third, continue to strengthen the supervision and management of commissioned production
(15) The provincial drug supervision and administration department shall effectively implement the territorial supervision responsibility, through the collection of entrusted production registration certificate information, urge enterprises to report production varieties, receive cross-regional production varieties notification and other ways and means, comprehensively sort out and grasp the number of various types of registrants and entrusted production enterprises in the administrative region, in accordance with the principle of risk management, targeted to strengthen supervision.
The provincial drug supervision and administration department where the registrant is located shall continue to pay attention to the registrant's quality management ability for the whole life cycle of medical devices, the evaluation and control ability of the entrusted manufacturing enterprise, and the change management ability, and verify the information provided by the registrant in combination with the inspection of the entrusted manufacturing enterprise. The provincial drug regulatory department where the entrusted manufacturer is located shall continue to pay attention to the production and quality management of the entrusted products, and urge the entrusted manufacturer to carry out production activities in accordance with regulations, rules, normative documents, mandatory standards, registered product technical requirements and entrusted production quality agreements.
(16) Where the registrant changes from self-production to commissioned production, or changes the commissioned production enterprise, it shall promptly report to the provincial drug regulatory 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, and the inspection of the entrusted production enterprise may be carried out jointly with the provincial drug regulatory department where the entrusted production enterprise is located.
(17) Drug regulatory departments at all levels shall deeply understand the complexity and particularity of the supervision of registrant entrusted production, scientifically equip regulatory resources, and enrich regulatory means.
In areas where registrants of commissioned production are relatively concentrated, the provincial drug supervision and administration department shall, in combination with the development of supervision work, regularly conduct special consultations on the supervision of commissioned production by registrants, analyze the results of supervision and inspection and product sampling, comprehensively investigate the safety risks existing in the enterprise quality management system and product quality, and take targeted prevention and control measures. Prevent systemic and regional risks.
Encourage drug supervision and administration departments to explore the two sites of registrants and entrusted manufacturers to carry out supervision and inspection simultaneously, connect the inspection site through information means such as remote network, communicate inspection information in a timely manner, and unify the inspection scale.
(18) The State Food and Drug Administration continues to promote the construction of medical device variety files and credit files, and promotes the interconnection of registrant entrusted production information by standardizing the registration certificate entrusted production information annotation; The provincial drug supervision and administration department shall realize the information of the whole chain of medical device supervision in the administrative area, collect the information of review and approval, registration quality management system verification, production licensing, supervision and inspection, enterprise report, supervision and sampling, illegal behavior investigation, and continue to update and improve the credit files of registrants and entrusted manufacturers. According to the requirements of the State Food and Drug Administration, it is pushed to the national drug regulatory data sharing platform to gradually realize cross-provincial regulatory information sharing.
Involving cross-regional commissioned production, the registrant and the provincial drug supervision and administration department where the commissioned production enterprise is located shall, in accordance with the requirements of the "Measures for the Supervision and Administration of Medical Device Production" and "Opinions on Strengthening the collaborative supervision of cross-regional commissioned production of Medical Devices", timely inform the enterprise's production varieties, inspection results and responsibility interviews and other regulatory information.
(19) Where the quality management system of the registrant or the entrusted production enterprise is found to be not operating effectively during supervision and inspection, the provincial drug regulatory department shall order it to rectify within a time limit; Where the registrant and the entrusted manufacturing 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 warning and responsibility interview, and when necessary, the registrant and the provincial drug regulatory department where the entrusted manufacturing enterprise is located may conduct joint responsibility interview.
If the registrant or the commissioned manufacturer seriously violates the production quality management norms of medical devices, and considers that the product is safe and effective after comprehensive investigation and judgment, and may harm human health, the provincial drug supervision and administration department may take emergency control measures to suspend the production, operation and use, and impose penalties strictly in accordance with Article 86 of the Regulations on the Supervision and Administration of Medical Devices.
(20) This Announcement shall take effect as of June 1, 2024.
Related website links:
https://www.cmde.org.cn/flfg/fgwj/ggtg/20240407104822145.html
For additional information regarding this alert, please contact:
VSCB Specialists
Email：Lisa.liu@vscbcorp.com