Measures for the Supervision and Administration of Online Sale of Medical Devices

Measures for the Supervision and Administration of Online Sale of Medical Devices Order of the China Food and Drug Administration (No. 38) 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. Director: Bi Jingquan December 20, 2017 Measures for the Supervision and Administration of Online Sale of Medical Devices Chapter I General Provisions 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. 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. 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. The provincial food and drug administrative departments shall be responsible for the supervision and administration of online trading services for medical devices. 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. 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. “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. “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. 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. 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. Chapter II Online Sale of Medical Devices 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Chapter III Online Trading Services for Medical Devices 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. 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: (1) the original and photocopy of the business license; (2) the originals and photocopies of the identifications of the legal representative or primary person in charge, and medical device quality and safety manager; (3) the explanations for the organizational structure......