【中英文对照版】医疗器械召回管理办法.docx
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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。
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