On June 21, in order to strengthen the supervision and management of network medical device operations, the State Food and Drug Administration organized the drafting of "Network Medical Devices" in accordance with the relevant requirements of the "Regulations on the Supervision and Administration of Medical Devices" and "Administrative Measures on Internet Information Services". The Administrative Supervision and Management Measures (Draft for Comment) is now open to the public for comments. All sectors of the community can log in to the Chinese government legal information network before July 22, 2017, and enter the "Regulations and Regulations Draft Collection System" on the left side of the homepage to make comments and suggestions. Food and Drug Administration June 21, 2017 Attachment Network Medical Device Management Supervision and Management Measures (Draft for Comment) Chapter I General Article 1 In order to strengthen the supervision and management of network medical device operation and ensure the safety of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Administration of Internet Information Services. Article 2 These Measures shall be complied with in the operation of network medical device operations within the territory of the People's Republic of China and the provision of third-party platform services for online medical device transactions. Article 3 The State Food and Drug Administration shall be in charge of the supervision and administration of the third-party platform for the nationwide network medical device operation and network medical device transaction service. The food and drug supervision and administration department at or above the county level shall be responsible for the supervision and administration of the third-party platform for network medical device operation and network medical device transaction service within its administrative region. Article 4 Third-party platforms for enterprises engaged in network medical device operation and network medical device transaction services shall abide by relevant laws and regulations of medical devices. Relevant enterprises shall operate in good faith according to law, abide by business ethics, comply with relevant norms, and ensure the quality and safety of medical devices. Article 5 Third-party platforms for enterprises engaged in network medical device operation and network medical device transaction services shall establish a network transaction quality and safety management system. Among them, the third-party platform for enterprises engaged in network medical device operation through self-built websites and network medical device transaction services should also have office space suitable for its scale, technical conditions such as data backup and fault recovery, and ensure network medical device operation data and data. Reliability, safety and traceability. Article 6 Third-party platforms for enterprises engaged in network medical device operation and network medical device transaction services shall actively cooperate with the food and drug supervision and administration department to carry out supervision and inspection work such as network monitoring, sampling inspection, on-site inspection, etc., in accordance with the requirements of the food and drug supervision and administration department. Information query, data extraction and other related support.
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