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Measures for the Supervision and Administration of Online Sale of Medical Devices [Effective]
医疗器械网络销售监督管理办法 [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. 38) (第38号)

The Measures for 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,现予公布,自2018年3月1日起施行。
Director: Bi Jingquan 局长:毕井泉
December 20, 2017 2017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办法
Chapter I General Provisions 

第一章 总 则

 
Article 1 For the purposes of strengthening the supervision and administration of online sale of medical devices and online trading services for medical devices, and protecting the security of the use of devices by the public, these Measures are developed according to the Cybersecurity Law of the People's Republic of China, the Regulation on the Supervision and Administration of Medical Devices, the Measures for the Administration of Internet Information Services and other laws and regulations.   第一条 为加强医疗器械网络销售和医疗器械网络交易服务监督管理,保障公众用械安全,根据《中华人民共和国网络安全法》《医疗器械监督管理条例》《互联网信息服务管理办法》等法律法规,制定本办法。
Article 2 These Measures shall apply to the online sale of medical devices, the provision of online trading services for medical devices and the supervision and administration thereof within the territory of the People's Republic of China.   第二条 在中华人民共和国境内从事医疗器械网络销售、提供医疗器械网络交易服务及其监督管理,应当遵守本办法。
Article 3 The China Food and Drug Administration (“CFDA”) shall be responsible for directing the supervision and administration of online sale of medical devices and online trading services for medical devices across the country, and organize the monitoring of online sale of and online trading services for medical devices.   第三条 国家食品药品监督管理总局负责指导全国医疗器械网络销售、医疗器械网络交易服务的监督管理,并组织开展全国医疗器械网络销售和网络交易服务监测。
The provincial food and drug administrative departments shall be responsible for the supervision and administration of online trading services for medical devices. 省级食品药品监督管理部门负责医疗器械网络交易服务的监督管理。
The local food and drug administrative departments at or above the county level shall be responsible for the supervision and administration of online sale of medical devices within their respective administrative regions. 县级以上地方食品药品监督管理部门负责本行政区域内医疗器械网络销售的监督管理。
Article 4 Enterprises engaging in online sale of medical devices or providers of third-party platforms for online trading services for medical devices shall comply with the laws, regulations, rules and specifications on medical devices, establish and improve the management system, conduct business with good faith according to the law, and guarantee the quality and safety of medical devices.   第四条 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应当遵守医疗器械法规、规章和规范,建立健全管理制度,依法诚信经营,保证医疗器械质量安全。
“Enterprises engaging in online sale of medical devices” means the holders of the marketing licensing of medical devices that sell medical devices online (i.e., registrants or recordation handling parties of medical devices, hereinafter referred to as “holders”) and enterprises engaging in production and business operation of medical devices. 从事医疗器械网络销售的企业,是指通过网络销售医疗器械的医疗器械上市许可持有人(即医疗器械注册人或者备案人,以下简称持有人)和医疗器械生产经营企业。
“Providers of third-party platforms for online trading services for medical devices” means enterprises that only provide webpage space, virtual trading venues, trading rules, match-making, electronic orders and other trading services in the online trading of medical devices, which are available for both or all trading parties to independently carry out trading activities, and that do not directly participate in the sale of medical devices. 医疗器械网络交易服务第三方平台提供者,是指在医疗器械网络交易中仅提供网页空间、虚拟交易场所、交易规则、交易撮合、电子订单等交易服务,供交易双方或者多方开展交易活动,不直接参与医疗器械销售的企业。
Article 5 Enterprises engaging in online sale of medical devices and providers of third-party platforms for online trading services for medical devices shall take technical measures to guarantee the authenticity, integrity and traceability of online sales data and materials of medical devices.   第五条 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应当采取技术措施,保障医疗器械网络销售数据和资料的真实、完整、可追溯。
Article 6 Enterprises engaging in online sale of medical devices and providers of third-party platforms for online trading services for medical devices shall actively cooperate with the food and drug administrative departments to conduct network monitoring, sampling inspection, on-site inspection and other supervision and administration, and store data, provide information inquiry, data extraction and other relevant support according to the requirements of the food and drug administrative departments.   第六条 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应当积极配合食品药品监督管理部门开展网络监测、抽样检验、现场检查等监督管理,按照食品药品监督管理部门的要求存储数据,提供信息查询、数据提取等相关支持。
Chapter II Online Sale of Medical Devices 

第二章 医疗器械网络销售

 
Article 7 An enterprise engaging in online sale of medical devices shall be an enterprise engaging in production and business operation of medical devices that has obtained the production permit and business permit for medical devices or has undergone the formalities of recordation according to the law, except under the circumstances of exemption from obtaining permit or undergo the formalities of recordation as prescribed in laws and regulations.   第七条 从事医疗器械网络销售的企业应当是依法取得医疗器械生产许可、经营许可或者办理备案的医疗器械生产经营企业。法律法规规定不需要办理许可或者备案的除外。
A holder selling medical devices online and a medical device manufacturer entrusted by the holder to sell medical devices manufactured upon commission online is not required to obtain any business permit or undergo formalities of recordation, but the sales conditions shall satisfy the requirements of the Regulation on the Supervision and Administration of Medical Devices and these Measures. 持有人通过网络销售其医疗器械,医疗器械生产企业受持有人委托通过网络销售受托生产的医疗器械,不需要办理经营许可或者备案,其销售条件应当符合《医疗器械监督管理条例》和本办法的要求。
A holder entrusting online sale of medical devices shall assess and confirm the legal qualification, sales conditions, technical level, and quality management capacity of the entrusted party, direct and supervise the online sale process and quality control, and be responsible for the quality of the medical devices sold online. 持有人委托开展医疗器械网络销售的,应当评估确认受托方的合法资质、销售条件、技术水平和质量管理能力,对网络销售过程和质量控制进行指导和监督,对网络销售的医疗器械质量负责。
Article 8 An enterprise engaging in online sale of medical devices shall enter the information sheet of online sale of medical devices, and undergo the recordation formalities with the food and drug administrative department at the districted city level in the place where it is located in advance for the enterprise name, legal representative or primary person in charge, website name, name of the online Client app, website domain name, website IP address, business permit for telecommunications services or recordation number of non-operational Internet information services, serial number of the license for the production and operation of medical devices or recordation certificate, and other information. Where the relevant information changes, the formalities of modification recordation shall be undergone in a timely manner.   第八条 从事医疗器械网络销售的企业,应当填写医疗器械网络销售信息表,将企业名称、法定代表人或者主要负责人、网站名称、网络客户端应用程序名、网站域名、网站IP地址、电信业务经营许可证或者非经营性互联网信息服务备案编号、医疗器械生产经营许可证件或者备案凭证编号等信息事先向所在地设区的市级食品药品监督管理部门备案。相关信息发生变化的,应当及时变更备案。
Article 9 An enterprise engaging in online sale of medical devices shall carry out online sale of medical devices through its own website or a third-party platform for online trading services for medical devices.   第九条 从事医疗器械网络销售的企业,应当通过自建网站或者医疗器械网络交易服务第三方平台开展医疗器械网络销售活动。
An enterprise engaging in online sale of medical devices through its own website shall obtain the Qualification Certificate for Internet Drug Information Services in accordance with the law, and have office premises, data backup, failure recovery and other technical conditions commensurate with its size. 通过自建网站开展医疗器械网络销售的企业,应当依法取得《互联网药品信息服务资格证书》,并具备与其规模相适应的办公场所以及数据备份、故障恢复等技术条件。
Article 10 An enterprise engaging in online sale of medical devices shall display its license for the production and operation of medical devices or recordation certificate in a conspicuous position on its homepage, and display the medical device registration certificate or recordation certificate of the product on the product page. The relevant information displayed shall be clear and easy to identify. The serial numbers of the license for the production and operation of medical devices or recordation certificate, and the medical device registration certificate or recordation certificate shall be displayed in the form of text. In the event of any change in the relevant information, the displayed contents shall be updated in a timely manner.   第十条 从事医疗器械网络销售的企业,应当在其主页面显著位置展示其医疗器械生产经营许可证件或者备案凭证,产品页面应当展示该产品的医疗器械注册证或者备案凭证。相关展示信息应当画面清晰,容易辨识。其中,医疗器械生产经营许可证件或者备案凭证、医疗器械注册证或者备案凭证的编号还应当以文本形式展示。相关信息发生变更的,应当及时更新展示内容。
Article 11 The name, model, specifications, structure and composition, scope of application, serial number of the medical device registration certificate or recordation certificate, information on the registrant or recordation handling party, serial number of the production permit or recordation certificate, serial number of the technical requirements for the product, contraindications, and other information on a medical device issued online by an enterprise engaging in online sale of medical devices shall be consistent with the relevant contents registered or recorded.   第十一条 从事医疗器械网络销售的企业在网上发布的医疗器械名称、型号、规格、结构及组成、适用范围、医疗器械注册证编号或者备案凭证编号、注册人或者备案人信息、生产许可证或者备案凭证编号、产品技术要求编号、禁忌症等信息,应当与经注册或者备案的相关内容保持一致。
Article 12 An enterprise engaging in online sale of medical devices shall record the information on sale of medical devices and keep it for a period of 2 years after the validity period of medical devices; the sales information on medical devices without validity period shall be kept for a period of not less than 5 years; and the sales information on implantable medical devices shall be kept permanently. Relevant records shall be authentic, complete and retrospective.   第十二条 从事医疗器械网络销售的企业应当记录医疗器械销售信息,记录应当保存至医疗器械有效期后2年;无有效期的,保存时间不得少于5年;植入类医疗器械的销售信息应当永久保存。相关记录应当真实、完整、可追溯。
Article 13 An enterprise engaging in online sale of medical devices shall not carry out business activities beyond the business scope as specified in the license for production and operation or recorded.   第十三条 从事医疗器械网络销售的企业,经营范围不得超出其生产经营许可或者备案的范围。
A medical device wholesale enterprise engaging in online sale of medical devices shall sell medical devices to qualified medical device business enterprises or using entities. 医疗器械批发企业从事医疗器械网络销售,应当销售给具有资质的医疗器械经营企业或者使用单位。
A medical device retail enterprise engaging in online sale of medical devices shall sell medical devices to consumers. The medical devices sold to individual consumers shall be able to be used by consumers themselves, and the instructions thereof shall comply with the manuals of medical devices and relevant provisions on label management, and indicate the special instructions for the safe use. 医疗器械零售企业从事医疗器械网络销售,应当销售给消费者。销售给消费者个人的医疗器械,应当是可以由消费者个人自行使用的,其说明书应当符合医疗器械说明书和标签管理相关规定,标注安全使用的特别说明。
Article 14 An enterprise engaging in online sale of medical devices shall store and transport medical devices according to the conditions as indicated in the labels and manuals of medical devices. An enterprise entrusting another entity to store or transport medical devices shall assess the capacity of the entrusted party for guaranteeing the quality of the medical devices to be stored and transported, specify the quality and safety liability during the storage and transportation process, and ensure the quality and safety during the process of storage and transportation.   第十四条 从事医疗器械网络销售的企业,应当按照医疗器械标签和说明书标明的条件贮存和运输医疗器械。委托其他单位贮存和运输医疗器械的,应当对被委托方贮存和运输医疗器械的质量保障能力进行考核评估,明确贮存和运输过程中的质量安全责任,确保贮存和运输过程中的质量安全。
Chapter III Online Trading Services for Medical Devices 

第三章 医疗器械网络交易服务

 
Article 15 A provider of a third-party platform for online trading services for medical devices shall obtain the Qualification Certificate for Internet Drug Information Services in accordance with the law, have office premises, data backup, failure recovery and other technical conditions commensurate with its size, and set up a special medical device network quality safety management institution or employ medical device quality safety management personnel.   第十五条 医疗器械网络交易服务第三方平台提供者应当依法取得《互联网药品信息服务资格证书》,具备与其规模相适应的办公场所以及数据备份、故障恢复等技术条件,设置专门的医疗器械网络质量安全管理机构或者配备医疗器械质量安全管理人员。
Article 16 A provider of a third-party platform for online trading services for medical devices shall undergo the recordation formalities with the provincial food and drug administrative department at the place where it is located, enter the recordation form of the third-party platform for online trading services for medical devices, and submit the following materials:   第十六条 医疗器械网络交易服务第三方平台提供者应当向所在地省级食品药品监督管理部门备案,填写医疗器械网络交易服务第三方平台备案表,并提交以下材料:
(1) the original and photocopy of the business license; (一)营业执照原件、复印件;
(2) the originals and photocopies of the identifications of the legal representative or primary person in charge, and medical device quality and safety manager; (二)法定代表人或者主要负责人、医疗器械质量安全管理人身份证明原件、复印件;
(3) the explanations for the organizational structure and setup of departments; (三)组织机构与部门设置说明;
(4) the originals and photocopies of the geological location map and house property right certificate or leasing agreement of the office place (with the house property right certificate annexed); (四)办公场所地理位置图、房屋产权证明文件或者租赁协议(附房屋产权证明文件)原件、复印件;
(5) the original and photocopy of the telecommunication business permit or the recordation explanation for the non-operational Internet information services; (五)电信业务经营许可证原件、复印件或者非经营性互联网信息服务备案说明;
(6) the original and photocopy of the Qualification Certificate for Internet Drug Information Services; (六)《互联网药品信息服务资格证书》原件、复印件;
(7) the catalogue of the rules on management of the quality of online trading services for medical devices and other documents; (七)医疗器械网络交易服务质量管理制度等文件目录;
(8) the introduction to and functional specification for the basic information on the website or online Client app; and (八)网站或者网络客户端应用程序基本情况介绍和功能说明;
(9) other relevant certification materials. (九)其他相关证明材料。
Article 17 The provincial food and drug administrative department shall check the integrity of the materials submitted by an enterprise on the spot, undergo the recordation formalities for an enterprise in compliance with the provisions, and grant a recordation certificate for a third-party platform for online trading services for medical devices there to; and notify an enterprise whose materials submitted are incomplete or that does not fall under the statutory circumstances of the materials to be supplemented at a time.   第十七条 省级食品药品监督管理部门应当当场对企业提交材料的完整性进行核对,符合规定的予以备案,发给医疗器械网络交易服务第三方平台备案凭证;提交资料不齐全或者不符合法定情形的,应当一次性告知需要补充材料的事项。
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