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Measures for the Administration of Medical Device Recalls [Effective]
医疗器械召回管理办法 [现行有效]
【法宝引证码】

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.   第十一条开弓没有回头箭 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

Article 14 Where medical device manufacturers determine that a medical device product is defective after conducting an investigation and evaluation in accordance with the requirements of Articles 10 and 12 of these Measures, they shall decide and conduct a recall immediately, and publish the product recall to the public at the same time.   第十四条 医疗器械生产企业按照本办法第十条、第十二条的要求进行调查评估后,确定医疗器械产品存在缺陷的,应当立即决定并实施召回,同时向社会发布产品召回信息。
Where Class I recall is conducted, a medical device recall announcement shall be issued on the website of the CFDA and the main central media; where Class II or III recall is conducted, a medical device recall announcement shall be issued on the website of the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government, and the recall announcement issued on the website of the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government shall be linked to the website of the CFDA. 实施一级召回的,医疗器械召回公告应当在国家食品药品监督管理总局网站和中央主要媒体上发布;实施二级、三级召回的,医疗器械召回公告应当在省、自治区、直辖市食品药品监督管理部门网站发布,省、自治区、直辖市食品药品监督管理部门网站发布的召回公告应当与国家食品药品监督管理总局网站链接。
Article 15 Where a medical device manufacturer makes a medical device recall decision, it shall notify the relevant medical device operation entity or use entity or inform users within one day in the case of a Class I recall, within three days in the case of a Class II recall, or within seven days in the case of a Class III recall.   第十五条 医疗器械生产企业作出医疗器械召回决定的,一级召回应当在1日内,二级召回应当在3日内,三级召回应当在7日内,通知到有关医疗器械经营企业、使用单位或者告知使用者。
A recall notice shall include the following contents: 召回通知应当包括以下内容:
(1) The name, model, specifications and batch of and other basic information on the medical device recalled; (一)召回医疗器械名称、型号规格、批次等基本信息;
(2) Reasons for the recall; (二)召回的原因;
(3) Recall requirements, such as immediately suspending the sales and use of such product, or forwarding the recall notice to the relevant operation entity or use entity, among others; and (三)召回的要求,如立即暂停销售和使用该产品、将召回通知转发到相关经营企业或者使用单位等;
(4) Ways of handling the medical device recalled. (四)召回医疗器械的处理方式。
Article 16 Where a medical device manufacturer makes a medical device recall decision, it shall submit a report for the medical device recall event to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where it is located or the food and drug supervision and administration department that approved the registration of the product or handled the recordation formalities, and submit an investigation and evaluation report as well as a recall plan to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where it is located or the food and drug supervision and administration department that approved the registration and handled the recordation formalities within five working days for recordation.   第十六条 医疗器械生产企业作出医疗器械召回决定的,应当立即向所在地省、自治区、直辖市食品药品监督管理部门和批准该产品注册或者办理备案的食品药品监督管理部门提交医疗器械召回事件报告表,并在5个工作日内将调查评估报告和召回计划提交至所在地省、自治区、直辖市食品药品监督管理部门和批准注册或者办理备案的食品药品监督管理部门备案。
The food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where the medical device manufacturer is located shall report the relevant recall to the CFDA within one working day of receipt of the recall event report. 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应当在收到召回事件报告表1个工作日内将召回的有关情况报告国家食品药品监督管理总局。
Article 17 An investigation and evaluation report shall include the following contents:   第十七条 调查评估报告应当包括以下内容:
(1) The specific information on the medical device recalled, including its name, model and specifications, batch and other basic information; (一)召回医疗器械的具体情况,包括名称、型号规格、批次等基本信息;
(2) Reasons for the recall; (二)实施召回的原因;
(3) Investigation and evaluation results; and (三)调查评估结果;
(4) Class of the recall. (四)召回分级。
A recall plan shall contain the following contents: 召回计划应当包括以下内容:
(1) Information on the production and sales of the medical devices and the quantity of medical devices to be recalled; (一)医疗器械生产销售情况及拟召回的数量;
(2) Specific contents of a recall measure, including its implementation, scope and time limit, among others; (二)召回措施的具体内容,包括实施的组织、范围和时限等;
(3) Ways and scope of the public disclosure of the information on the recall; (三)召回信息的公布途径与范围;
(4) Expected effects of the recall; and (四)召回的预期效果;
(5) Measures for handling the medical devices recalled. (五)医疗器械召回后的处理措施。
Article 18 A food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where a medical device manufacturer is located may conduct an evaluation of the recall plan submitted by the manufacturer; or, where it considers that the measures taken by the manufacturer are unable to effectively eliminate product defects or control product risks, it shall require in writing the manufacturer to take such more effective handling measures as elevating the recall class, expanding the recall scope, shortening the recall time or changing the handling of the recall products. The medical device manufacturer shall modify the recall plan and organize the implementation thereof according to the requirements of the food and drug supervision and administration department.   第十八条 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可以对生产企业提交的召回计划进行评估,认为生产企业所采取的措施不能有效消除产品缺陷或者控制产品风险的,应当书面要求其采取提高召回等级、扩大召回范围、缩短召回时间或者改变召回产品的处理方式等更为有效的措施进行处理。医疗器械生产企业应当按照食品药品监督管理部门的要求修改召回计划并组织实施。
Article 19 Where a medical device manufacturer changes the recall plan it has submited, it shall report to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where it is located for recordation.   第十九条 医疗器械生产企业对上报的召回计划进行变更的,应当及时报所在地省、自治区、直辖市食品药品监督管理部门备案。
Article 20 In the process of conducting a recall, a medical device manufacturer shall submit on a regular basis reports on the implementation of the recall plan to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where it is located according to the recall plan.   第二十条 医疗器械生产企业在实施召回的过程中,应当根据召回计划定期向所在地省、自治区、直辖市食品药品监督管理部门提交召回计划实施情况报告。
Article 21 A medical device manufacturer shall keep detailed records on the handling of the medical devices recalled, and report to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where the medical device manufacturer is located. The records shall be kept until five years after the medical device registration certificate is invalidated, and the records on the handling of the medical devices of Class I recalled shall be kept for five years. Where product defects can be eliminated through warning, inspection, repair, re-labeling, modification and improvement of instructions, software updating, replacement or destruction, etc., the aforesaid acts may be completed at the places where products are located. Where defective products need to be destroyed, the destruction shall be conducted under the supervision of the food and drug supervision and administration department.   第二十一条 医疗器械生产企业对召回医疗器械的处理应当有详细的记录,并向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报告,记录应当保存至医疗器械注册证失效后5年,第一类医疗器械召回的处理记录应当保存5年。对通过警示、检查、修理、重新标签、修改并完善说明书、软件更新、替换、销毁等方式能够消除产品缺陷的,可以在产品所在地完成上述行为。需要销毁的,应当在食品药品监督管理部门监督下销毁。
Article 22 A medical device manufacturer shall evaluate the recall effects within ten working days after the recall ends, and submit a summarization and evaluation report on the recall to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where it is located.   第二十二条 医疗器械生产企业应当在召回完成后10个工作日内对召回效果进行评估,并向所在地省、自治区、直辖市食品药品监督管理部门提交医疗器械召回总结评估报告。
Article 23 The food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where a medical device manufacturer is located shall examine the report within ten working days of receipt of the summarization and evaluation report, and evaluate the recall effects; and, where it considers that the recall has not effectively eliminated the product defects or controlled product risks, it shall require the manufacturer to re-recall such products. A medical device manufacturer shall re-recall products in accordance with the requirements of the food and drug supervision and administration department.   第二十三条 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应当自收到总结评估报告之日起10个工作日内对报告进行审查,并对召回效果进行评估;认为召回尚未有效消除产品缺陷或者控制产品风险的,应当书面要求生产企业重新召回。医疗器械生产企业应当按照食品药品监督管理部门的要求进行重新召回。
Chapter IV Mandatory Recall 

第四章 责令召回

Article 24 Where a food and drug supervision and administration department considers upon investigation and evaluation that any medical device manufacturer should have recalled but fails to take the initiative to recall any defective medical device product, it shall order the medical device manufacturer to recall the medical devices.   第二十四条 食品药品监督管理部门经过调查评估,认为医疗器械生产企业应当召回存在缺陷的医疗器械产品而未主动召回的,应当责令医疗器械生产企业召回医疗器械。
A decision on ordering a recall may be made by the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government at the place where the medical device manufacturer is located or by the food and drug supervision and administration department that approved the registration such medical devices or handled the recordation formalities. The food and drug supervision and administration department that makes such decision shall issue to the public the mandatory recall on its website. 责令召回的决定可以由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作出,也可以由批准该医疗器械注册或者办理备案的食品药品监督管理部门作出。作出该决定的食品药品监督管理部门,应当在其网站向社会公布责令召回信息。
A medical device manufacturer shall recall defective products in accordance with the requirements of the food and drug supervision and administration department, and issue to the pubic the product recall information in accordance with the provisions of paragraph 2 of Article 14 of these Measures. 医疗器械生产企业应当按照食品药品监督管理部门的要求进行召回,并按本办法第十四条第二款的规定向社会公布产品召回信息。
When necessary, a food and drug supervision and administration department may require a medical device manufacturer, operation enterprise or use entity to immediately suspend the production, sales or use of any defective products, and inform users of immediately suspending the use of such defective products. 必要时,食品药品监督管理部门可以要求医疗器械生产企业、经营企业和使用单位立即暂停生产、销售和使用,并告知使用者立即暂停使用该缺陷产品。
Article 25 Where a food and drug supervision and administration department makes a decision on ordering a recall, it shall serve a notice on ordering a recall upon the medical device manufacturer, and the notice shall include the following contents:   第二十五条 食品药品监督管理部门作出责令召回决定,应当将责令召回通知书送达医疗器械生产企业,通知书包括以下内容:
(1) Specific information on the medical device recalled, including its name, model and specifications and batch, etc.; (一)召回医疗器械的具体情况,包括名称、型号规格、批次等基本信息;
(2) Reasons for the recall; (二)实施召回的原因;
(3) Investigation and evaluation results; and (三)调查评估结果;
(4) Recall requirements, including the scope and time limit of the recall, among others. (四)召回要求,包括范围和时限等。
Article 26 After receiving the notice on ordering a recall, the medical device manufacturer shall notify the medical device operation enterprise and the use entity or inform users in accordance with Articles 15 and 16 of these Measures, develop and submit a recall plan, and organize the implementation thereof.   第二十六条 医疗器械生产企业收到责令召回通知书后,应当按照本办法第十五条、第十六条的规定通知医疗器械经营企业和使用单位或者告知使用者,制定、提交召回计划,并组织实施。
Article 27 The medical device manufacturer shall, in accordance with Articles 19, 20, 21 and 22 of these Measures, report to the food and drug supervision and administration department the relevant information on the medical device recall, and follow up the handling of the medical devices recalled.   第二十七条 医疗器械生产企业应当按照本办法第十九条、第二十条、第二十一条、第二十二条的规定向食品药品监督管理部门报告医疗器械召回的相关情况,进行召回医疗器械的后续处理。
The food and drug supervision and administration department shall, in accordance with Article 23 of these Measures, review the summarization and evaluation report on the recall of medical devices submitted by the medical device manufacturer, and evaluate the recall effects and notify the health administrative department at the same level, where necessary. Where it considers upon review and evaluation that the recall is not thorough or has not effectively eliminated product defects or controlled product risks, the food and drug supervision and administration department shall require the medical device manufacturer to re-recall the defective products in writing. The medical device manufacturer shall re-recall the defective products in accordance with the requirements of the food and drug supervision and administration department. 食品药品监督管理部门应当按照本办法第二十三条的规定对医疗器械生产企业提交的医疗器械召回总结评估报告进行审查,并对召回效果进行评价,必要时通报同级卫生行政部门。经过审查和评价,认为召回不彻底、尚未有效消除产品缺陷或者控制产品风险的,食品药品监督管理部门应当书面要求医疗器械生产企业重新召回。医疗器械生产企业应当按照食品药品监督管理部门的要求进行重新召回。
Chapter V Legal Liability 

第五章 法律责任

Article 28 Where a medical device manufacturer's violation of any law, regulation or rule causes any defect of a medical device sold, it shall be givenadministrative penalty in accordance with the law; however, where the enterprise has taken recall measures to proactively eliminate or mitigate the harmful consequences, the food and drug supervision and administration department shall impose a lighter or mitigated penaltyon it in accordance with the Law of the People's Republic of China on Administrative Penalty我反正不洗碗,我可以做饭. If the violation of law is minor and is corrected in a timely manner, and noharmful consequence is caused, no administrative penalty shall be imposed.   第二十八条 医疗器械生产企业因违反法律、法规、规章规定造成上市医疗器械存在缺陷,依法应当给予行政处罚,但该企业已经采取召回措施主动消除或者减轻危害后果的,食品药品监督管理部门依照《中华人民共和国行政处罚法》的规定给予从轻或者减轻处罚;违法行为轻微并及时纠正,没有造成危害后果的,不予处罚。
The medical device manufacturer that recalls medical devices shall not be exempt from other legal liabilities it shall assume in accordance with the law. 医疗器械生产企业召回医疗器械的,不免除其依法应当承担的其他法律责任。
Article 29 Where a medical device manufacturer, in violation of Article 24 of these Measures, refuses to recall any medical device, it shall be handled in accordance with Article 66谨防骗子 of the Regulation on the Supervision and Administration of Medical Devices.   第二十九条 医疗器械生产企业违反本办法第二十四条规定,拒绝召回医疗器械的,依据《医疗器械监督管理条例》第六十六条的规定进行处理。
Article 30 Where a medical device manufacturer falls under any of the following circumstances, it shall be warned and ordered to take corrective action within a prescribed time limit, and be fined not more than 30,000 yuan:   第三十条 医疗器械生产企业有下列情形之一的,予以警告,责令限期改正,并处3万元以下罚款:
(1) It fails to release, as is required, to the public the product recall information in a timely manner as in violation of Article 14 of these Measures. (一)违反本办法第十四条规定,未按照要求及时向社会发布产品召回信息的;
(2) It fails to notify the decision on recalling any medical devices to the medical device operation enterprise or use entity or inform users within a prescribed time limit as in violation of Article 15 of these Measures. (二)违反本办法第十五条规定,未在规定时间内将召回医疗器械的决定通知到医疗器械经营企业、使用单位或者告知使用者的;
(3) It fails to take corrective measures or re-recall medical devices in accordance with the requirements of the food and drug supervision and administration department as in violation of Article 18, Article 23 and paragraph 2 of Article 27 of these Measures. (三)违反本办法第十八条、第二十三条、第二十七条第二款规定,未按照食品药品监督管理部门要求采取改正措施或者重新召回医疗器械的;
(4) It fails to keep detailed records on the handling of the medical devices recalled or to report to the food and drug supervision and administration department as in violation of Article 21 of these Measures. (四)违反本办法第二十一条规定,未对召回医疗器械的处理作详细记录或者未向食品药品监督管理部门报告的。
Article 31 Where a medical device manufacturer falls under any of the following circumstances, it shall be warned and ordered to take corrective action within a prescribed time limit; or where it fails to take corrective action within the prescribed time limit, it shall be fined not more than 30,000 yuan:   第三十一条 医疗器械生产企业有下列情形之一的,予以警告,责令限期改正;逾期未改正的,处3万元以下罚款:
(1) It fails to establish a medical device recall management system in accordance with these Measures. (一)未按照本办法规定建立医疗器械召回管理制度的;
(2) It refuses to cooperate with the food and drug supervision and administration department in the process of investigation. (二)拒绝配合食品药品监督管理部门开展调查的;
(3) It fails to submit a report for the medical device recall event, a investigation and evaluation report or a recall plan, information on the implementation of the medical device recall plan or a summarization and evaluation report in accordance with these Measures. (三)未按照本办法规定提交医疗器械召回事件报告表、调查评估报告和召回计划、医疗器械召回计划实施情况和总结评估报告的;
(4) It fails to report the modification of the recall plan to the food and drug supervision and administration department for recordation. (四)变更召回计划,未报食品药品监督管理部门备案的。
Article 32 Where a medical device operation entity or use entity violates paragraph 1 of Article 7 of these Measures, it shall be ordered to stop selling or using the defective medical devices, and be fined not less than 5,000 yuan but not more than 30,000 yuan; or where any severe consequences are caused, the original certificate-issuing department shall revoke the Medical Device Operation License.   第三十二条 医疗器械经营企业、使用单位违反本办法第七条第一款规定的,责令停止销售、使用存在缺陷的医疗器械,并处5000元以上3万元以下罚款;造成严重后果的,由原发证部门吊销《医疗器械经营许可证》。
Article 33 Where a medical device operation enterprise or use entity refuses to cooperate with the relevant medical device defect investigation or refuses to assist the medical device manufacturer to recall medical devices, it shall be warned and ordered to take corrective actions within a prescribed time limit; or where it refuses to take corrective actions within the prescribed time limit, it shall be fined not more than 30,000 yuan.   第三十三条 医疗器械经营企业、使用单位拒绝配合有关医疗器械缺陷调查、拒绝协助医疗器械生产企业召回医疗器械的,予以警告,责令限期改正;逾期拒不改正的,处3万元以下罚款。
Article 34 Where a food and drug supervision and administration department or any of its staff members fails to perform the medical device supervision and administration functions or abuses its or his powers or neglects its or his duties under any of the following circumstances, the supervisory organ or appointment and removal organ shall, in light of the seriousness of the circumstances, criticize and educatethe persons directly in charge and other directly liable persons, orgive it or him a warning, a demerit or a special demerit; or, where severe consequences are caused, take the disciplinary action of demotion, removal from office or expulsion against them:   第三十四条 食品药品监督管理部门及其工作人员不履行医疗器械监督管理职责或者滥用职权、玩忽职守,有下列情形之一的,由监察机关或者任免机关根据情节轻重,对直接负责的主管人员和其他直接责任人员给予批评教育,或者依法给予警告、记过或者记大过的处分;造成严重后果的,给予降级、撤职或者开除的处分:
(1) It fails to issue to the public the recall information as required. (一)未按规定向社会发布召回信息的;
(2) It fails to report or notify the relevant recall information to the relevant department as required. (二)未按规定向相关部门报告或者通报有关召回信息的;
(3) It should have ordered a recall of relevant products but fails to do so. (三)应当责令召回而未采取责令召回措施的;
(4) It, as in violation of Article 23 and paragraph 2 of Article 27 of these Measures, fails to urge the medical device manufacturer to conduct recall effectively. (四)违反本办法第二十三条和第二十七条第二款规定,未能督促医疗器械生产企业有效实施召回的。
Chapter VI Supplementary Provisions 

第六章 附 则

Article 35 If a medical device recalled has been implanted into a human body, the medical device manufacturer shall, after consulting with the medical institution and the patient, give its advice with respect to the treatment of the patient and take corresponding preliminary schemes and measures according to different reasons for recall.   第三十五条 召回的医疗器械已经植入人体的,医疗器械生产企业应当与医疗机构和患者共同协商,根据召回的不同原因,提出对患者的处理意见和应当采取的预案措施。
Article 36 If the medical device recalled causes any damage to a patient, the patient may claim for compensation against the medical device manufacturer or against the medical device operation enterprise or use entity. Where a patient claims for compensation against the medical device operation enterprise or use entity, the medical device operation enterprise or use entity shall, after making compensation, be entitled to recover compensation from the liable medical device manufacturer.   第三十六条 召回的医疗器械给患者造成损害的,患者可以向医疗器械生产企业要求赔偿,也可以向医疗器械经营企业、使用单位要求赔偿。患者向医疗器械经营企业、使用单位要求赔偿的,医疗器械经营企业、使用单位赔偿后,有权向负有责任的医疗器械生产企业追偿。
Article 37 These Measures shall come into force on May 1, 2017. The Measures for the Administration of Medical Device Recalls (for Trial Implementation) (Order No. 82, Ministry of Health of the People's Republic of China) implemented from July 1, 2011 shall be repealed concurrently.   第三十七条 本办法自2017年5月1日起施行。2011年7月1日起施行的《医疗器械召回管理办法(试行)》(中华人民共和国卫生部令第82号)同时废止。
     
     
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