【中英文对照版】医疗器械网络销售监督管理办法.docx

《【中英文对照版】医疗器械网络销售监督管理办法.docx》由会员分享，可在线阅读，更多相关《【中英文对照版】医疗器械网络销售监督管理办法.docx（21页珍藏版）》请在得力文库 - 分享文档赚钱的网站上搜索。

1、医疗器械网络销售监督管理方法Measures for the Supervision and Administration of Online Sale of Medical Devices【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38号发布日期：实施日期：效力级别：部门规章法规类别：医疗器械药品药材进出口互联网Issuing Authority : China Food and Drug Administration (dissolved)Document Number : Order No. 38 of the Chin

2、a Food and Drug AdministrationDate Issued ： 12-20-2017Effective Date ： 03-01-2018Level of Authority : Departmental RulesArea of Law : Import and Export of Medical Devices, Drugs, and Medicine Materials InternetOrder of the China Food and Drug Administration国家食品药品监督管理总局令(No. 38)（第38号）The Measures for

3、 the Supervision and Administration of Online Sale of Medical Devices, as deliberated and adopted at the executive meeting of the China Food and Drug Administration on November 7, 2017, are hereby issued and shall come into force on March 1, 2018.医疗器械网络销售监督管理办 法已于2017年11月7日经国 家食品药品监督管理总局局务会 议审议通过，现予

4、公布，自 2018年3月1日起施行。Director: Bi Jingquan局长：毕井泉December 20, 20172017年12月20日Measures for the Supervision and Administration of Online Sale of Medical Devices医疗器械网络销售监督管理方法Chapter I General Provisions第一章总那么authentic, complete and retrospective.保存。相关记录应当真实、完 整、可追溯。Article 23 A provider of a third-party p

5、latform for online trading services for medical devices shall monitor the sale of medical devices and the information on the platform, and shall, when discovering that an enterprise registered on a third-party platform for online trading services carries out business activities beyond the business s

6、cope, issues false information, conducts exaggerated publicity and has other acts in violation of laws and regulations, is unavailable, or has other serious safety loopholes, immediately cease the online trading services therefor, keep relevant records, and report to the provincial food and drug adm

7、inistrative department in the place where it is located.第二十三条医疗器械网络 交易服务第三方平台提供者应当 对平台上的医疗器械销售行为及 信息进行监测，发现入驻网络交 易服务第三方平台的企业存在超 范围经营、发布虚假信息、夸大 宣传等违法违规行为、无法取得 联系或者存在其他严重平安隐患 的，应当立即对其停止网络交易 服务，并保存有关记录，向所在 地省级食品药品监督管理部门报 告。When finding that an enterprise registered on a third-party platform for online

8、trading services is ordered by the food and drug administrative department to cease production and business, and is subject to revocation of permits and other penalties, or the sale of products traded on the platform is suspended or ceased by the food and drug administrative department, a provider s

9、hall immediately cease the provision of relevant online trading services.发现入驻网络交易服务第三方平 台的企业被食品药品监督管理部 门责令停产停业、撤消许可证件 等处分，或者平台交易的产品被 食品药品监督管理部门暂停销售 或者停止销售的，应当立即停止 提供相关网络交易服务。Article 24 A provider of a third-party platform for online trading services for medical devices shall, in a conspicuous positi

10、on at its website, issue potential product quality safety risks and other information in a timely manner.第二十四条医疗器械网络 交易服务第三方平台提供者应当 在网站醒目位置及时发布产品质 量平安隐患等相关信息。Chapter IV Supervision and Inspection第四章监督检查Article 25 The food and drug administrative department shall, in accordance with the provisions of

11、 laws, regulations and rules, conduct supervision and inspection and sampling inspection of the enterprises engaging in online sale of medical devices and third-party platforms for online trading services for medical devices according to the functions.第二十五条食品药品监督 管理部门依照法律、法规、规章 的规定，依职权对从事医疗器械 网络销售的企

12、业和医疗器械网络 交易服务第三方平台实施监督检10查和抽样检验。第二十六条对从事医疗器 械网络销售的企业违法行为的查 处，由其所在地县级以上地方食 品药品监督管理部门管辖。未经许可或者备案从事医疗器械 网络销售，能确定违法销售企业 地址的，由违法销售企业所在地 县级以上地方食品药品监督管理 部门管辖；不能确定违法销售企 业所在地的，由违法行为发生地 或者违法行为结果地的县级以上 地方食品药品监督管理部门管 辖。通过医疗器械网络交易服务 第三方平台销售的，由医疗器械 网络交易服务第三方平台提供者 所在地省级食品药品监督管理部 门管辖；经调查后能够确定管辖 地的，及时移送有管辖权的食品 药品监督管

13、理部门。对医疗器械网络交易服务第三方 平台提供者违法行为的查处，由 其所在地省级食品药品监督管理 部门管辖。网络销售的医疗器械发生重大质 量事故或者造成其他严重危害后 果的，可以由违法企业所在地、 违法行为发生地或者违法行为结 果地省级食品药品监督管理部门 管辖；后果特别严重的，省级食 品药品监督管理部门可以报请国 家食品药品监督管理总局协调或 者组织直接查处。Article 26 The investigation and punishment of the enterprises engaging in online sale of medical devices that have ac

14、ts in violation of the law shall be governed by the local food and drug administrative department at or above the county level in the place where it is located.Where an enterprise engages in online sale of medical devices without obtaining a permit or undergoing recordation formalities and the locat

15、ion of the enterprise selling products illegally is able to be determined, the investigation and punishment shall be governed by the local food and drug administrative department at or above the county level in the enterprise selling products illegally where it is located; where the location of the

16、enterprise selling products illegally is unable to be determined, the investigation and punishment shall be governed by the local food and drug administrative department at or above the county level in the place where illegal sale is conducted or where the results of the illegal sale occur. Where pr

17、oducts are sold on a third-party platform for online trading services for medical devices, the investigation and punishment shall be governed by the provincial food and drug administrative department in the place where the provider of the third-party platform for online trading services for medical

18、devices is located; and where the region with jurisdiction is able to be determined upon investigation, the case shall be transferred to the food and drug administrative department with jurisdiction in a timely manner.The investigation and punishment of the illegal acts of a provider of a third-part

19、y platform for online trading services for medical devices shall be governed by the provincial food and drug administrative department in the place where it is located.Where a medical device sold online causes a major quality accident or any other serious hazardous consequences, the investigation an

20、d punishment shall be governed by the provincial food and drug administrative department in the place where the illegal enterprise is located, where illegal sale is conducted or where the results of the illegal sale occur; and where the consequences are particularly serious, the provincial food and

21、drug administrative department may submit a request to the CFDA for coordination or organization of direct investigation and punishment.11The provincial food and drug administrative department shall notify the competent communications department at the same level of the website that illegally conduc

22、ts online sale of medical devices.Article 27 The CFDA shall organize the establishment of a national monitoring platform for online trading of medical devices, monitor and handle online sale and online trading of medical devices across the country, and report the monitoring situation to the provinci

23、al food and drug administrative departments on a regular basis. The information on suspected violations of laws and regulations found in monitoring shall be transferred to the relevant provincial food and drug administrative department in a timely manner. The provincial food and drug administrative

24、department shall organize the handling in a timely manner.Article 28 The monitoring platforms for online sale of medical devices independently established by the provincial food and drug administrative department shall realize data connection with the national monitoring platform for online trading

25、of medical devices.Article 29 When conducting routine supervision and administration of online sale of medical devices or investigating and punishing enterprises conducting online sale of medical devices that are suspected of violating laws and regulations, the food and drug administrative departmen

26、t shall have the right to take the following measures:第二十九条食品药品监督 管理部门开展医疗器械网络销售 日常监督管理，或者对涉嫌违法 违规的医疗器械网络销售行为进 行查处时，有权采取以下措施：(1) entering the medical device business premises, office premises and locations of servers of the enterprises to conduct on-site inspection;对发生医疗器械网络销售违法行 为的网站，由省级食品药品监督 管理部门

27、通报同级通信主管部 门。对发生医疗器械网络销售违法行 为的网站，由省级食品药品监督 管理部门通报同级通信主管部 门。第二十七条国家食品药品 监督管理总局组织建立国家医疗 器械网络交易监测平台，开展全 国医疗器械网络销售和网络交易 监测与处置，监测情况定期通报 省级食品药品监督管理部门。对 监测发现的涉嫌违法违规信息， 及时转送相关省级食品药品监督 管理部门。省级食品药品监督管 理部门应当及时组织处理。第二十八条省级食品药品 监督管理部门自行建立的医疗器 械网络销售监测平台，应当与国 家医疗器械网络交易监测平台实 现数据对接。(-)进入企业医疗器械经营场 所、办公场所和服务器所在地等 实施现场检

28、查；(2) conducting sampling inspections of the medical devices to (二)对网络销售的医疗器械进 be sold online;行抽样检验；inquiring about relevant persons, and investigating the relevant information on enterprises online sales of medical devices;(三)询问有关人员，调查企业 从事医疗器械网络销售行为的相 关情况；12consulting and copying the transaction d

29、ata, contracts, commercial papers, account books and other relevant materials of the enterprise;(3) obtaining the technical monitoring and recording materials on online sale;seizing and detaining data storage media, among others according to the law; and(4) other measures that may be taken as prescr

30、ibed by laws and regulations.Article 30 Sampling inspection of medical devices to be sold online shall be conducted according to the relevant administrative provisions on the quality supervision and sampling inspection of medical devices.If the inspection results do not meet the quality and safety s

31、tandards for medical devices, the food and drug administrative department shall, upon receipt of an inspection report, conduct supervision and inspection of the relevant production and operation enterprise in a timely manner, take control measures, issue quality announcement in a timely manner, and

32、investigate and punish violators according to the law.第三十一条食品药品监督 管理部门对医疗器械网络销售的 技术监测记录、信息追溯资料Article 31 The food and drug administrative department may regard the technical monitoring records or information traceability materials on online sale of medical devices as the basis for determining the il

33、legal facts in online sale of medical devices.（四）查阅、复制企业的交易数 据、合同、票据、账簿以及其他 相关资料；（五）调取网络销售的技术监 测、记录资料；（六）依法查封扣押数据存储介 质等；（七）法律、法规规定可以采取 的其他措施。第三十条对网络销售医疗 器械的抽样检验，按照医疗器械 质量监督抽查检验相关管理规定 实施。检验结果不符合医疗器械质量安 全标准的，食品药品监督管理部 门收到检验报告后，应当及时对 相关生产经营企业开展监督检 查，采取控制措施，及时发布质 量公告，对违法行为依法查处。等，可以作为认定医疗器械网络 销售违法事实的依据。A

34、rticle 32 Where the actual situation of an enterprise engaging in online sale of medical devices is inconsistent with the recordation information and the enterprise is unable to be contacted, upon announcement by the food and drug administrative department at the districted city level in the place w

35、here it is located, its Medical Device Operation Permit shall be revoked according to the law or a mark shall be indicated in第三十二条从事医疗器械 网络销售的企业实际情况与备案 信息不符且无法取得联系的，经 所在地设区的市级食品药品监督 管理部门公示后，依法注销其 医疗器械经营许可证或者在第三十二条从事医疗器械 网络销售的企业实际情况与备案 信息不符且无法取得联系的，经 所在地设区的市级食品药品监督 管理部门公示后，依法注销其 医疗器械经营许可证或者在13第二类医疗器械

36、经营备案信息中 予以标注，并向社会公告。相关 网站由省级食品药品监督管理部 门通报同级通信主管部门。第二类医疗器械经营备案信息中 予以标注，并向社会公告。相关 网站由省级食品药品监督管理部 门通报同级通信主管部门。the recordation information on operation of Class II medical devices and be announced to the public. The provincial food and drug administrative department shall notify the competent communicat

37、ions department at the same level of the relevant website.医疗器械网络交易服务第三方平 台提供者实际情况与备案信息不 符且无法取得联系的，经原备案 所在地省级食品药品监督管理部 门公示后，在其备案信息中予以 标注，向社会公告；备案时提供Where the actual situation of a provider of a third-party platform for online trading services for medical devices is inconsistent with the recordation i

38、nformation and the provider is unable to be contacted, upon announcement by the provincial food and drug administrative department in the place where the original recordation formalities are undergone, a mark shall be indicated in the recordation information and be announced to虚假资料的，由省级食品药品监 督管理部门向社

39、会公告备案单 位。其网站由省级食品药品监督 管理部门通报同级通信主管部 门。虚假资料的，由省级食品药品监 督管理部门向社会公告备案单 位。其网站由省级食品药品监督 管理部门通报同级通信主管部 门。the public; and where false materials are provided in recordation, the provincial food and drug administrative department shall announce the recordation entity to the public. The provincial food and dru

40、g administrative department shall notify the competent communications department at the same level of its website.第三十三条食品药品监督 管理部门在检查中发现从事医疗 器械网络销售的企业或者医疗器 械网络交易服务第三方平台未按 规定建立并执行相关质量管理制 度，且存在医疗器械质量平安隐 患的，食品药品监督管理部门可 以责令其暂停网络销售或者暂停 提供相关网络交易服务。Article 33 Where a food and drug administrative department

41、 finds in the inspection that an enterprise engaging in online sale of medical devices or a third-party platform for online trading services for medical devices fails to establish and implement a relevant quality management system as required and has potential quality and safety risks in medical dev

42、ices, the food and drug administrative department may order it to suspend online sale or suspend the provision of relevant online trading services.恢复网络销售或者恢复提供相关 网络交易服务的，从事医疗器械 网络销售的企业或者医疗器械网 络交易服务第三方平台提供者应 当向原作出处理决定的食品药品 监督管理部门提出申请，经食品 药品监督管理部门检查通过后方 可恢复。To resume online sale or provision of releva

43、nt online trading services, an enterprise engaging in online sale of medical devices or a provider of a third-party platform for online trading services for medical devices shall file an application with the food and drug administrative department that originally makes a decision of handling, and ma

44、y only resume online sale or provision of relevant online trading services after passing the examination of the food and drug administrative department.第三十四条从事医疗器械 网络销售的企业、医疗器械网络 交易服务第三方平台提供者，有Article 34 Where an enterprise engaging in online sale of medical devices or a provider of a third-party pl

45、atform for online trading services for medical devices falls under one of the following circumstances, the food and drug administrative14以下情形之一的，食品药品监督 管理部门可以依职责对其法定代department may, according to the functions, hold an interview with its legal representative or primary person in charge:表人或者主要负责人进行约谈:

46、(1) A quality and safety problem of medical devices occurs and may lead to quality and safety risks in medical devices.（-）发生医疗器械质量平安问 题，可能引发医疗器械质量平安 风险的；(2) It fails to appropriately handle the quality problems of medical devices complained and tipped off, and may have potential quality and safety r

47、isks in medical devices.（二）未及时妥善处理投诉举报 的医疗器械质量问题，可能存在 医疗器械质量平安隐患的；(3) It fails to take effective measures in a timely manner to check and eliminate the potential quality and safety risks in medical devices and fails to fulfill the responsibilities for the quality and safety of medical devices.（三）未及时

48、采取有效措施排 查、消除医疗器械质量平安隐 患，未落实医疗器械质量平安责 任的；(4) Other circumstances under which an interview is necessary to be held.（四）需要进行约谈的其他情 形。An interview shall not affect the administrative punishment imposed by the food and drug administrative department according to the law, and the interview and follow-up punishment may be disclosed to the public.约谈不影响食品药品监督管理部 门依法对其进行行政处理，约谈 情况及后续处理情况可以向社会 公开。Where an enterprise with which an interview is held fails to implement rectification as required without any justifiable reason, the provincial food and drug adm