Networked medical equipment, 197 companies, 1509 sites were investigated!

January 11 hearing on January 10, the State Food and Drug Administration held a press briefing, the State Food and Drug Administration Director of Supervision of the main device on the "Medical Device Network Sales Supervision and Management Measures" (hereinafter referred to as the "Measures"), The main content of the medical device network regulatory situation for interpretation and analysis.

In 2017, the State Food and Drug Administration launched a special inspection of sales of medical device network focusing on medical devices such as sodium hyaluronate injection and soft contact lens, and focused on network monitoring and complaint reporting information, focusing on investigating sales Unregistered medical device products, the company did not obtain the "medical device manufacturing license," "medical device business license," or the second category of medical equipment business registration certificate that the sale of products on the network and other illegal activities. The special action, A total of 1,509 illegal websites were investigated and punished, rectification and reform of 440 production and operation enterprises, and investigation and punishment of 197 illegal production and operation enterprises.

With the continuous development of "Internet +", the integration of medical device industry and the Internet has accelerated, and the operation of medical device networks has become increasingly active. However, at the same time, the issue of using network to sell unregistered medical devices and falsely exaggerating propaganda and cheating consumers continues appear.

In the third party online trading service platform and some websites illegally selling undocumented products appear to give the people a greater risk of mechanical safety.To implement the "measures" in depth this year, the State Food and Drug Administration will focus on the development of medical equipment Network sales supervision, crack down on illegal use of the network to sell unlicensed medical devices and other illegal activities.

"Measures" in line with the principle of "online and offline consistent", made it clear that the scope of network sales of medical equipment shall not exceed the scope of its production and operation license or filing.

In addition, according to the requirements of the Medical Devices Retailing and Wholesale Enterprises in the Measures for the Supervision and Administration of Medical Device Operation, the Measures also stipulate that medical device wholesale enterprises shall engage in sales of medical device networks and should sell to qualified medical device enterprises or use Units; medical equipment retailers engaged in medical equipment sales network, should be sold to consumers.

Medical devices sold to individual consumers should be self-use by consumers, and their instructions shall conform to the medical device manuals and labeling regulations, with special instructions for safe use.

The Measures clarify the responsibility of third-party platform providers (hereinafter referred to as 'third-party platform providers') of medical device network transaction services and regulatory authorities, and especially require that the procedures for the verification of enterprise presence, quality and safety monitoring, transaction security and illegalities Behavior suppression, protection of consumer rights and other important duties at the same time, the responsibility and obligation to develop a penalty clause.

For third-party platform providers who fail to effectively fulfill the main responsibility, food drug Regulators will investigate and punish according to law.

In addition, the "Measures" also provides that food and drug regulatory authorities found that third-party platform providers do not establish and implement the relevant quality management system in accordance with the regulations, and there medical instruments Quality and safety hazards, you can order it to suspend the provision of related network transaction services; the existence of medical device quality and safety issues, may lead to quality and safety risks of medical devices and so on, according to the duties of its legal representative or principal responsible person for interviews.

For refusing to implement the provision of online trading services to suspend the suspension or after being interviewed refused to comply with the requirements of third-party platform providers can be their legal representative or principal responsible for the loss of credit enterprise And dishonest list, and to the public.

In our country engaged in medical equipment sales network, belonging to a kind of medical equipment business, to deal with the sale of medical equipment product quality Responsible for ensuring the safety and effectiveness of medical devices.

Should be in accordance with the "Regulations on the Supervision and Administration of Medical Devices" and other provisions of the scale and scope of business operations and storage conditions compatible with the operation of medical equipment and quality management system and quality management institutions or personnel, and obtain business license Or for the record.

"Measures" mentioned that the State Food and Drug Administration is responsible for organizing the construction of medical equipment network transaction monitoring platform.

In 2016, the State Food and Drug Administration has started to organize the establishment of a national medical device network transaction monitoring platform, and the monitoring platform construction project is divided into three phases. At present, the first phase of the monitoring platform has been completed and the second phase of construction is open Bidding Work has been completed.

During the trial operation of the monitoring platform, the data collection and monitoring has been carried out on the large-scale e-commerce platform and the websites that have the Internet drug information service qualification certificate, and the monitored illegal and illegal information is promptly transferred to the relevant food and drug regulatory authorities in the provinces (districts and municipalities) for investigation Processing, medical equipment sales network supervision and management played an active role.