Provincial food and drug supervision and management departments are responsible for the supervision and management of medical device network trading services.
Local food and drug supervision and management departments at or above the county level shall be responsible for the supervision and management of the online sale of medical devices in the administrative area. Article 4 Enterprises engaged in the online sale of medical devices, medical device network trading services third-party platform providers shall comply with medical device laws, regulations and norms, establish and improve the management system, in accordance with the law and integrity of the business, to ensure the quality and safety of medical devices.
Enterprises engaged in the sale of medical devices network, refers to the sale of medical devices through the network of medical device marketing license holder (i.e., medical device registrant or filer, hereinafter referred to as the holder) and medical device production and management enterprises.
Medical device network trading services third-party platform provider, refers to the medical device network trading only to provide web space, virtual trading place, trading rules, transaction aggregation, electronic orders and other trading services for trading parties or more parties to carry out trading activities, not directly involved in the sale of medical devices. Article 5 enterprises engaged in medical device network sales, medical device network trading services third-party platform providers should take technical measures to protect the medical device network sales data and information is true, complete and traceable. Article 6 Enterprises engaged in the online sale of medical devices, medical device network trading services third-party platform provider shall actively cooperate with the food and drug supervision and management department to carry out network monitoring, sampling and testing, on-site inspection and other supervision and management, in accordance with the requirements of the food and drug supervision and management department to store data, provide information query, data extraction and other related support. Chapter II Network Sales of Medical Devices Article 7 Enterprises engaged in the network sales of medical devices should be legally licensed to obtain a medical device production license, business license or for the record of the production and operation of medical devices. Laws and regulations do not require licensing or filing except.
Holder through the network sales of medical devices, medical device manufacturers entrusted by the holder through the network sales of medical devices commissioned to produce, do not need to apply for a license or record, the conditions of sale should be consistent with the "Supervision and Management of Medical Devices Regulations" and the requirements of these measures.
The holder entrusted to carry out network sales of medical devices, shall assess and confirm the legal qualifications of the entrusted party, sales conditions, technical level and quality management capabilities, the network sales process and quality control to guide and supervise the network sales process and quality control, the quality of medical devices sold on the network is responsible. Article 8 Enterprises engaged in network sales of medical devices, should fill out the medical device network sales information form, the enterprise name, legal representative or principal, website name, network client application name, website domain name, website IP address, telecommunications business license or non-operational Internet information service filing number, medical device production and operation of licenses or filing credentials number and other information Prior to the location of the municipal food and drug supervision and management departments for the record. Changes in the relevant information should be changed in a timely manner for the record. Article IX engaged in the sale of medical devices network of enterprises, should be through the self-built website or medical device network trading services third-party platform to carry out online sales activities of medical devices.
Through the self-built website to carry out network sales of medical devices, the enterprise shall obtain the "Internet Drug Information Service Qualification Certificate", and with its size appropriate office space and data backup, fault recovery and other technical conditions. Article 10 Enterprises engaged in the online sale of medical devices shall prominently display their medical device production and operation licenses or filing certificates on the main page, and the product page shall display the product's medical device registration certificate or filing certificate. Relevant display information should be clear and easy to recognize. Among them, the medical device production and management license or record certificate, medical device registration certificate or record certificate number should also be displayed in text form. Changes in the relevant information should be updated in a timely manner to display the content. Article XI engaged in the online sale of medical devices in the online release of the medical device name, model, specifications, structure and composition, scope of application, medical device registration certificate number or certificate number for the record, the registrant or the filing of information, the production license or certificate number for the record, the technical requirements of the product number, contraindications, and other information should be registered or filed by the relevant content to maintain consistency. Article XII engaged in the sale of medical devices network should record the sales of medical devices, records should be kept until 2 years after the expiration date of the medical device; no expiration date, the retention time shall not be less than 5 years; implantable medical devices sales information should be permanently preserved. The relevant records shall be true, complete and traceable.