Online medical devices should be wired offline entities

The State Administration of Food and Drug Administration recently held a press conference to interpret and analyze the "Measures for the Supervision and Administration of The Sale of Medical Devices Network" and the regulatory situation for the operation of medical device networks. The relevant person in charge of the Medical Device Supervision Department of the State Administration of Food and Drug Administration stressed that the Measures clearly state that the supervision of the online and offline sales of medical devices follows the principle of "online and offline agreement", which means that there is no corresponding offline entity enterprises that may not sell medical devices through the network;
the introduction of the introduction, with the rapid development of medical device network sales, the use of the network illegal sale of unregistered medical devices, false exaggerated publicity, cheating consumers continue to appear. At the same time, the virtual nature of network management, cross-regional, hidden, easy transfer and so on, but also lead to unclear regulatory jurisdiction responsibilities, means lag, investigation and evidence-taking difficulties, lack of basis for law enforcement and other issues.
for the network business scope of enterprises engaged in the network sales of medical devices, the Measures clearly state that they shall not exceed the scope of their production and operation license or record-keeping. When a medical device wholesale enterprise engages in the online sale of medical devices, it shall sell it to a qualified medical device operating enterprise or unit of use; Medical devices sold to consumers should be for personal use by consumers themselves, and their instructions shall comply with the relevant regulations on the management of medical device instructions and labels, with special instructions for safe use. (Health News)