| Order of the China Food and Drug Administration | | 国家食品药品监督管理总局令 |
| (No. 29) | | （第29号） |
| The Measures for the Administration of Medical Device Recalls, as deliberated and adopted at the executive meeting of the China Food and Drug Administration (“CFDA”) on January 5, 2017, is hereby issued, and shall come into force on May 1, 2017. | | 《医疗器械召回管理办法》已于2017年1月5日经国家食品药品监督管理总局局务会议审议通过，现予公布，自2017年5月1日起施行。 |
| Director: Bi Jingquan | | 局长：毕井泉 |
| January 25, 2017 | | 2017年1月25日 |
| Measures for the Administration of Medical Device Recall | | 医疗器械召回管理办法 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 In order to strengthen the supervision and administration of medical devices, control defective medical device products, eliminate the hidden safety risks of medical devices, ensure the safety and effectiveness of medical devices, and protect human health and life safety, these Measures are developed in accordance with the Regulation on the Supervision and Administration of Medical Devices. | | 第一条 为加强医疗器械监督管理，控制存在缺陷的医疗器械产品，消除医疗器械安全隐患，保证医疗器械的安全、有效，保障人体健康和生命安全，根据《医疗器械监督管理条例》，制定本办法。 |
| Article 2 These Measures shall apply to the recall of medical devices that have been sold within the territory of the People's Republic of China and the supervision and administration thereof. | | 第二条 中华人民共和国境内已上市医疗器械的召回及其监督管理，适用本办法。 |
| Article 3 For the purpose of these Measures, “medical device recall” means a medical device production enterprise's act of handling defective medical device products of certain categories, models or batches which have been sold through warning, inspection, repair, re-labeling, modification and improvement of instructions, software updating, replacement, recovery or destruction or other methods under the prescribed procedures. | | 第三条 本办法所称医疗器械召回，是指医疗器械生产企业按照规定的程序对其已上市销售的某一类别、型号或者批次的存在缺陷的医疗器械产品，采取警示、检查、修理、重新标签、修改并完善说明书、软件更新、替换、收回、销毁等方式进行处理的行为。 |
| “Medical device manufacturers” as mentioned in the preceding paragraph means theapplicants for the registration or recordation of medical devices within the territory of China and the agents designated by the overseas manufacturers of imported medical devices within the territory of China. | | 前款所述医疗器械生产企业，是指境内医疗器械产品注册人或者备案人、进口医疗器械的境外制造厂商在中国境内指定的代理人。 |
| Article 4 For the purpose of these Measures, “defective medical device products” shall include: | | 第四条 本办法所称存在缺陷的医疗器械产品包括： |
| (1) products which have unreasonable risks that may endanger human health and life safetyunder the circumstances of normal use; | | （一）正常使用情况下存在可能危及人体健康和生命安全的不合理风险的产品； |
| (2) products that do not comply the compulsory standards or the technical requirements for products that have been registered or undergone recordation formalities; | | （二）不符合强制性标准、经注册或者备案的产品技术要求的产品； |
| (3) products that may have unreasonable risks due to their failure to comply with the relevant provisions on medical device production and operation quality management; and | | （三）不符合医疗器械生产、经营质量管理有关规定导致可能存在不合理风险的产品； |
| (4) other products that need to be recalled. | | （四）其他需要召回的产品。 |
| Article 5 Medical device manufacturers are the parties responsible for the control and elimination of product defects, and shall take the initiative to recall defective products. | | 第五条 医疗器械生产企业是控制与消除产品缺陷的责任主体，应当主动对缺陷产品实施召回。 |
| Article 6 Medical device manufacturers shall, in accordance with these Measures, establish and improve the medical device recall management system, collect the relevant information on the safety of medical devices, investigate and evaluate the possibly defective products, and recall defective products in a timely manner. | | 第六条 医疗器械生产企业应当按照本办法的规定建立健全医疗器械召回管理制度，收集医疗器械安全相关信息，对可能的缺陷产品进行调查、评估，及时召回缺陷产品。 |
| The agents designated by the overseas manufacturers of imported medical devices within the territory of China shall only report the relevant information on the recall of medical devices abroad to the CFDA in a timely manner. Where the recall of defective medical deviceswithin the territory of China is involved, the agents designated within the territory of China shall organize the implementation thereof in accordance with the provisions of these Measures. | | 进口医疗器械的境外制造厂商在中国境内指定的代理人应当将仅在境外实施医疗器械召回的有关信息及时报告国家食品药品监督管理总局；凡涉及在境内实施召回的，中国境内指定的代理人应当按照本办法的规定组织实施。 |
| Medical device operation enterprises and use entities shall actively assist medical device manufacturers in investigating and evaluating defective products, take the initiative to cooperate with manufacturers in fulfilling the recall obligations, transmit and return the medical device recall information in a timely manner according to the recall plans, and control and recover defective products. | | 医疗器械经营企业、使用单位应当积极协助医疗器械生产企业对缺陷产品进行调查、评估，主动配合生产企业履行召回义务，按照召回计划及时传达、反馈医疗器械召回信息，控制和收回缺陷产品。 |
| Article 7 Where any medical device operation enterprise or use entity finds that the medical devices it operates or uses may be defective products, it shall immediately suspend the sale or use of such medical devices, notify the medical device manufacturer or supplier in a timely manner, and report to thefood and drug supervision and administrationdepartment of the province, autonomous region or municipality directly under the Central Government at the place where it is located; or where the use entity is a medical institution, it shall also report to the health administrative departmentof the province, autonomous region or municipality directly under the Central Government at the place where it is located. | | 第七条 医疗器械经营企业、使用单位发现其经营、使用的医疗器械可能为缺陷产品的，应当立即暂停销售或者使用该医疗器械，及时通知医疗器械生产企业或者供货商，并向所在地省、自治区、直辖市食品药品监督管理部门报告；使用单位为医疗机构的，还应当同时向所在地省、自治区、直辖市卫生行政部门报告。 |
| Thefood and drug supervision and administrationdepartment of the province, autonomous region or municipality directly under the Central Government at the place where the medical device operation enterprise or use entity is located shall, after receiving the report, notify the food and drug supervision and administrationdepartment of the province, autonomous region or municipality directly under the Central Government at the place where the medical device manufacturer is located in a timely manner. | | 医疗器械经营企业、使用单位所在地省、自治区、直辖市食品药品监督管理部门收到报告后，应当及时通报医疗器械生产企业所在地省、自治区、直辖市食品药品监督管理部门。 |
| Article 8 The food and drug supervision and administrationdepartments of the provinces, autonomous regions or municipalities directly under the Central Government at the places where the manufacturers that recall medical devices are located shall take charge of the supervision and administration of medical device recalls, and the food and drug supervision and administrationdepartments of other provinces, autonomous regions or municipalities directly under the Central Government shall cooperate with them in effectively conducting the relevant work on the medical device recalls within their respective administrative regions. | | 第八条 召回医疗器械的生产企业所在地省、自治区、直辖市食品药品监督管理部门负责医疗器械召回的监督管理，其他省、自治区、直辖市食品药品监督管理部门应当配合做好本行政区域内医疗器械召回的有关工作。 |
| The CFDA shall supervise the administration of medical device recall nationwide. | | 国家食品药品监督管理总局监督全国医疗器械召回的管理工作。 |
| Article 9 The CFDA and thefood and drug supervision and administrationdepartments of the provinces, autonomous regions or municipalities directly under the Central Government shall, in accordance with the relevant system for notification and public disclosure of medical device recall information, publish defective product information and recall information by taking effective means, and notify the relevant information to the health administrative departments at the same levels when necessary. | | 第九条 国家食品药品监督管理总局和省、自治区、直辖市食品药品监督管理部门应当按照医疗器械召回信息通报和信息公开有关制度，采取有效途径向社会公布缺陷产品信息和召回信息，必要时向同级卫生行政部门通报相关信息。 |
| Chapter II Investigation and Evaluation of Medical Device Defects | | 第二章 医疗器械缺陷的调查与评估 |
| Article 10 Medical device manufacturers shall, in accordance with the relevant provisions, establish and improve the medical device quality management system and the medical deviceadverse event monitoring system, collect and record the information on medical device quality complaints and adverse events, analyze the information collected, and investigate and evaluate possible defects. | | 第十条 医疗器械生产企业应当按照规定建立健全医疗器械质量管理体系和医疗器械不良事件监测系统，收集、记录医疗器械的质量投诉信息和医疗器械不良事件信息，对收集的信息进行分析，对可能存在的缺陷进行调查和评估。 |
| Medical devices operation enterprises and use entities shall cooperate with medical device manufacturers in investigating relevant medical device defects, and provide the relevant materials. | | 医疗器械经营企业、使用单位应当配合医疗器械生产企业对有关医疗器械缺陷进行调查，并提供有关资料。 |
| Article 11 Medical device manufacturers shall, in accordance with the relevant provisions, report the collected information on medical device adverse events tothe food and drug supervision and administrationdepartments in a timely manner, andfood and drug supervision and administrationdepartments may analyze and investigate medical device adverse events or possible defects, and medical device manufacturers, operation enterprises and use entities shall give support thereto. | | 第十一条 医疗器械生产企业应当按照规定及时将收集的医疗器械不良事件信息向食品药品监督管理部门报告，食品药品监督管理部门可以对医疗器械不良事件或者可能存在的缺陷进行分析和调查，医疗器械生产企业、经营企业、使用单位应当予以配合。 |
| Article 12 The evaluation of defective medical device products shall primarily include the following contents: | | 第十二条 对存在缺陷的医疗器械产品进行评估的主要内容包括： |
| (1) Whether such products comply with the compulsory standards or the technical requirements for products that have been registered or undergone recordation formalities; | | （一）产品是否符合强制性标准、经注册或者备案的产品技术要求； |
| (2) Whether such products have ever broken down or caused any damage when they were used; | | （二）在使用医疗器械过程中是否发生过故障或者伤害； |
| (3) Whether such products may cause damages under the existing use environment, and whether any scientific literature, research or relevant tests or verification can interpret the reasons for the damages incurred; | | （三）在现有使用环境下是否会造成伤害，是否有科学文献、研究、相关试验或者验证能够解释伤害发生的原因； |
| (4) Scope of regions and characteristics of the people involved by the damages; | | （四）伤害所涉及的地区范围和人群特点； |
| (5) Degree of damages to human health; | | （五）对人体健康造成的伤害程度； |
| (6) Probability of the occurrence of damages; | | （六）伤害发生的概率； |
| (7) Short- and long-term consequences of the damages; and | | （七）发生伤害的短期和长期后果； |
| (8) Other factors that may damage human bodies. | | （八）其他可能对人体造成伤害的因素。 |
| Article 13 Medical device recall is divided into the following classes based on defect severity of medical devices: | | 第十三条 根据医疗器械缺陷的严重程度，医疗器械召回分为： |
| (1) Class I recall: the use of such medical devices may cause or has caused severe health hazards. | | （一）一级召回：使用该医疗器械可能或者已经引起严重健康危害的； |
| (2) Class II recall: the use of such medical devices may cause or has caused temporary or medically reversible health hazards. | | （二）二级召回：使用该医疗器械可能或者已经引起暂时的或者可逆的健康危害的； |
| (3) Class III recall:the use of such medical devices is less likely to cause damages but recall is still necessary. | | （三）三级召回：使用该医疗器械引起危害的可能性较小但仍需要召回的。 |
| Medical device manufacturers shall determine the recall classes according to the specific circumstances, and design the recall plans in a scientific manner and organize the implementation thereof according to the recall classes and the sales and use of medical devices. | | 医疗器械生产企业应当根据具体情况确定召回级别并根据召回级别与医疗器械的销售和使用情况，科学设计召回计划并组织实施。 |
Chapter IIITaking the Initiative to Recall Defective Products
．．．．．． | | 第三章 主动召回
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