【中英文对照版】医疗器械召回管理办法.docx

《【中英文对照版】医疗器械召回管理办法.docx》由会员分享，可在线阅读，更多相关《【中英文对照版】医疗器械召回管理办法.docx（22页珍藏版）》请在得力文库 - 分享文档赚钱的网站上搜索。

1、医疗器械召回管理方法Measures for the Administration of Medical Device Recalls【中英文对照版】发布部门：国家食品药品监督管理总局(已撤销)发文字号：中华人民共和国国家食品药品监督管理总局令第29号发布日期：实施日期：效力级别：部门规章法规类别：医疗保健Issuing Authority : China Food and Drug Administration (dissolved)Document Number : Order No. 29 of the China Food and Drug AdministrationDate Iss

2、ued : 01-25-2017Effective Date ： 05-01-2017Level of Authority : Departmental RulesArea of Law : Health CareOrder 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

3、the China Food and Drug Administration (CFDA) on January 5, 2017, is hereby issued, and shall come into force on May 1, 2017.医疗器械召回管理方法 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, 20172017年1月25日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

4、 the medical device recalled.（四）召回医疗器械的处理 方式。suspending the sales and use of such product, or forwarding the recall notice to the relevant operation entity or use entity, among others; and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

5、 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。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。第十七条调查评估报 告应当包括以下内容：Article 16 Where a medical device manufacturer makes a medical device recall decision, it shall submit a report for the medical device recall e

6、vent 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 o

7、r 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 o

8、r the food and drug supervision and administration department that approved the registration and handled the recordation formalities within five working days for recordation.The food and drug supervision and administration department of the province, autonomous region or municipality directly under

9、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.Article 17 An investigation and evaluation report shall include the following contents:10The specific informa

10、tion on the medical device recalled, including its name, model and specifications, batch and other basic information;(1) Reasons for the recall;Investigation and evaluation results; and(2) Class of the recall.A recall plan shall contain the following contents:(1) Information on the production and sa

11、les of the medical devices and the quantity of medical devices to be recalled;Specific contents of a recall measure, including its implementation, scope and time limit, among others;(2) Ways and scope of the public disclosure of the information on the recall;Expected effects of the recall; and（一）召回医

12、疗器械的具体 情况，包括名称、型号规 格、批次等基本信息；（二）实施召回的原因；（三）调查评估结果；（四）召回分级。召回计划应当包括以下内容：（一）医疗器械生产销售情 况及拟召回的数量；（二）召回措施的具体内 容，包括实施的组织、范围 和时限等；（三）召回信息的公布途径 与范围；（四）召回的预期效果;(5) Measures for handling the recalled.medical devices （五）医疗器械召回后的处 理措施。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

13、产品缺陷或者控制产品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 manufactur

14、er; or, where it considers that the measures taken by the manufacturer are unable to effectively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。eliminate product defects or control product risks, it shall require in writing the manufacturer to t

15、ake 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 requi

16、rements of the food and drug supervision and administration department.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 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

17、 the province, autonomous region or municipality directly under the Central Government at the place where it is located for recordation.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。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

18、5年，第一类医疗器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 t

19、he Central Government at the place where it is located according to the recall plan.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, autonom

20、ous 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 records12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

21、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。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。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, inspe

22、ction, 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 sup

23、ervision of the food and drug supervision and administration department.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 admini

24、stration department of the province, autonomous region or municipality directly under the Central Government at the place where it is located.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。

25、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

26、 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 acc

27、ordance with the requirements of the food and drug supervision and administration department.13第四章责令召回第四章责令召回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Chapter IV Mandatory RecallWhere a food and drug supervision and administration department considers upon investigation and evaluation that any

28、medical device manufacturer should have recalled but fails to take the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。initiative to recall any defective medical device product, it shall order the medical device manufacturer to recall the medical devices.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

29、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 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 manufact

30、urer 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 r

31、ecall on its website.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，并按本方法第 十四条第二款的规定向社会 公布产品召回信息。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

32、 accordance with the provisions of paragraph 2 of Article 14 of these Measures.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。When necessary, a food and drug supervision and administration department may require a medical device manufacturer, operation enterprise or use enti

33、ty to immediately suspend the production, sales or use of any defective products, and inform users of immediately suspending the use of such defective products.14Where a food and drug supervision and administration department makes a decision on ordering a recall, it shall serve a notice on ordering

34、 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：（一）召回医疗器械的具体 情况，包括名称、型号规(1) Specific information on the medical device recalled, including its name, model and specificationsand batch, etc.;

35、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。第二十六条医疗器械Article 26 After receiving the notice on ordering a recall, the medical device man

36、ufacturer 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.生产企业收到责令召回通知 书后，应当按照本方法第十 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

37、，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 rec

38、alled.第二十七条医疗器械 生产企业应当按照本方法第十九条、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，15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。第五章法律责任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

39、政处分，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 民共和国行政处分法的规 定给予从轻或者减轻处分； 违法行为轻微并及时纠正， 没有造成危害后果的，不予 处分。进行召回医疗器械的后续处 理。The food and drug supervision and administration 食品药品监督管理部门应当department shall, in accordance with Article 23 of 按照本方法第二十三条的规these Measures, review the summarization and evaluation re

40、port 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

41、 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 rerecall the defective products in accordance with

42、the requirements of the food and drug supervision and administration department.Chapter V Legal LiabilityWhere a medical device manufacturers 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; howev

43、er, 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 Peoples Republic of China on Administrative

44、 Penalty. 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.16The medical device manufacturer that recalls medical devices shall not be exempt from other legal liabilities it shall assume in accordanc

45、e with the law.Article 28 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 of the Regulation on the Supervision and Administration of Medical Devices.Article 29 Where a medical d

46、evice 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:(1) It fails to release, as is required, to the public the product recall information in a timely manner

47、as in violation of Article 14 of these Measures.(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.(3) It fails to take corrective

48、 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.医疗器械生产企业召回医疗 器械的，不免除其依法应当 承当的其他法律责任。第二十九条医疗器械 生产企业违反本方法第二十 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。第三十条医疗器械生 产企业有以下情形之一的， 予以警告，责令限期改正， 并处3万元以下罚款：（一）违反本方法第十四条 规定，未按照要求及时向社 会发布产品召回信息的；（二）违反本方法第十五条 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；（三）违反本方法第十八 杀、弟一十二杀、弟一十七 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；17(4) It fails