Interpretation of "Medical Device Network Sales Supervision and Management Measures"

Pharmaceutical Network Dec. 25 hearing to strengthen the network of medical equipment sales and medical equipment network transaction services supervision and management, to ensure the safety of public use of machinery, the State Food and Drug Administration formulated and promulgated the "medical device network sales supervision and management approach" (hereinafter referred to as " Measures "), the" Measures "will come into force on March 1, 2018. The relevant questions are as follows:

In recent years, a series of policies have been promulgated by the state to further reduce the obstacles to the institutional mechanisms that constrain the development of e-commerce. With the advent of the "Internet +" move, the integration of the medical device industry and the Internet has been accelerating and network sales of medical devices have become increasingly active. At the same time, the use of online sales of fake and shoddy medical equipment, fake exaggerated propaganda, deceiving consumers continue to emerge, for example, in the network e-commerce platform, direct website or mobile client illegally sales of unregistered medical device products, the release of illegal Information and other acts frequently appear to bring potential risks to the people using mechanical safety.At the same time, due to the characteristics of network sales such as virtuality, trans-regionality, occultness, and ease of transfer, the regulatory authority is unclear, regulatory tools are lagging behind, Investigation and evidence collection difficulties, lack of law enforcement basis and many other problems.Therefore, improve the network of medical equipment sales Regulations From the system level to further clarify the main responsibility for medical equipment sales network and regulatory responsibilities, to strengthen the regulatory means and measures for medical device network sales, and continue to regulate business practices and crack down on network medical device sales violations is of great significance.Therefore, according to "network Security Law "and" Medical Device Supervision Regulations "and other laws and regulations, combined with the General Office of the CPC Central Committee and the General Office of the State Council on deepening the reform review and approval system reform and encourage the innovation of medical devices, medical devices and network management requirements of the actual needs of national food sales The Measures are formulated by the State Administration of Food and Drug Administration with a total of 50 measures including legislative purposes, scope of application, enterprises engaged in the sale of medical devices and networks, obligations of third-party platform providers for medical device network transaction services, supervision and administration, and legal responsibilities And so on.

Second, what are the differences between "enterprises engaged in the sales of medical device networks" and "third-party platform providers of medical device network transaction services" mentioned in the Measures?

The Measures stipulate the principle of 'online and offline consistency'. Enterprises engaged in network sales of medical devices shall have the main body of application for obtaining the medical device manufacturing license, business license or filing entity and the conditions for the sale of the medical device manufacturing enterprises, Medical Device Licensing Holders (ie, medical device registrants or fillers) required by the Regulations and the Regulations of the Medical Device Administration shall operate through self-built websites (including web client applications) or medical device networks Third-party trading services platform for sales of medical equipment.

Third-party platform provider of medical device network transaction service refers to providing transaction services such as web space, virtual transaction sites, trading rules, transaction matching and electronic orders in the medical device network transaction for trading activities of both parties or parties of the transaction, and not Directly involved in the sale of medical equipment business.

In addition, the "Measures" also clearly stipulates the medical device network information service in accordance with the "Internet drug Information Services Management Measures. "Therefore, through self-built Web site medical instruments Internet sales enterprise And third-party platform providers of medical device network transaction services shall obtain Internet drug information service qualification certificates in accordance with the "Measures for the Administration of Internet Drug Information Services".

Third, the "Measures" engaged in the sale of medical equipment and medical equipment business network services third-party platform provider provides what are the main obligations?

One is to fulfill the filing obligations.Equipment engaged in the sale of medical devices should be located to the district where the municipal food and drug administration for the record, the relevant information changes, it should promptly change the record information.Medical equipment, online trading services, third-party platform provider It shall file with the food and drug regulatory department at the provincial level where it is located and make changes in the record-keeping information as soon as possible.

The second is the establishment of medical device quality management system.Medical device network transaction platform for third-party providers should establish and implement the platform for the registration of medical device manufacturing enterprises to verify the registration, quality and safety monitoring, transaction security, stop the illegal sales and reporting network, Serious violations of platform services to stop, report security complaints processing, protection of consumer rights, quality and safety information bulletin management system.

The third is to review the registration obligations.Medical equipment online trading platform for third-party providers should apply for the platform for the medical device manufacturing enterprises to provide medical equipment production and operation license or record voucher, medical device registration certificate or record voucher, business license, etc. Materials to verify the registration, the establishment of the file and promptly updated, and settled with the platform for the medical device manufacturing enterprises signed an agreement to settle the obligations and non-compliance measures and other relevant content.

Fourth, the qualification, location, technical conditions and the relevant requirements of management personnel engaged in network sales of medical devices and medical equipment online trading platform for third-party providers should be made in accordance with the law, "Internet drug information service qualification certificate", with its scale to adapt Office space and data backup, fault recovery and other technical conditions, set up a special medical device network quality and safety management agencies or medical device quality and safety management personnel.

Fifth, platform management obligations. Third-party platform providers of medical device network transactions should be on the platform for the sale of medical devices and information monitoring and found that the third party network trading services platform for the existence of illegal medical device manufacturing enterprises should be immediately It stops the network transaction service and keeps relevant records and reports to the provincial food and drug supervision and administration department where it locates.It is found that the medical device manufacturing and operation enterprises that settled in the third party platform of online trading service are ordered to stop production and suspension of business and revocation of licenses by the food and drug supervision and administration department , It should immediately stop providing online trading services.

Sixth, record obligations. Engaged in medical device network sales of medical equipment and network transactions Third-party platform providers should record medical device transaction information, records should be kept to the medical equipment valid for 2 years; no period of validity, the preservation of time shall not be less than 5 Year; implant medical device transaction information should be kept forever .Those should take technical measures to ensure the medical device network sales data and information is true and complete, safety traceability.

Fourth, "Measures" in the provisions of the network of medical equipment sales business network what is the scope?

Medical device network business scope shall not exceed the scope of its production and operation license or filing.Medical device wholesale enterprises engaged in medical device network sales should be sold to qualified medical device management enterprises or use units.Medical device retailers engaged in medical device network sales, Should be sold to individual consumers. Sales of medical devices to individual consumers should be self-use by consumers themselves, and their instructions should be consistent with medical device manuals and labeling management regulations, marked safety instructions for use. Should be medical Medical devices used by agencies can not be sold to individuals.

Five, "approach" for the sale of medical equipment network storage and distribution requirements.

An enterprise engaged in the sales of medical device network shall store and transport the medical device in accordance with the label of the medical device and the conditions specified in the instruction book and entrust other units to store and transport the medical device, Evaluate and clarify the quality responsibility of storage and transportation to ensure quality and safety during storage and transportation.

Sixth, "Measures" at all levels of food and drug regulatory division responsibilities.

The State Food and Drug Administration is responsible for supervising and supervising the nationwide sale of medical device network and the third-party platform for the medical device network transaction service and organizing the nationwide sales of medical device network monitoring. The provincial-level food and drug supervision and administration department is responsible for the medical device network transaction Service supervision and management of third-party platform.Local food and drug administrations above the county level shall be responsible for the supervision and administration of sales of medical device networks within their respective administrative regions.

Seven, "measures" on the sale of medical equipment network quality and safety risk prevention and control measures.

During the inspection, the food and drug supervision and administration department found that the third-party platform for the enterprises or medical equipment online trading service that failed to establish and implement the relevant quality management system for the enterprises engaged in the sales of medical device networks and the existence of quality and safety hazards of medical devices may order it to suspend the network Sell ​​or suspend the provision of related online trading services.

Found that engaged in the sale of medical devices or medical devices online trading services third-party platform for the existence of medical device quality and safety issues that may lead to quality and safety risks of medical devices and so on, according to their duties to the legal representative or principal responsible person to interview .

In addition, harm to the human body or evidence of possible harm to the human body health Of the medical equipment, "Medical Device Supervision and Management Ordinance" has made it clear that the food and drug administration may suspend the production, import, operation and use of emergency control measures.

Eight, "measures" on the illegal medical device sales network, medical device network transaction services provider of third-party platform for the primary responsible person's disciplinary measures.

The Measures not only clarify the legal liability of third-party platform providers of equipment network sales enterprises and medical device network transaction services, but also provide disciplinary measures for relevant responsible persons. For refusing to implement the suspension of online sales, the provision of related online transaction services is suspended or After being interviewed and refusing to rectify as required, the third party platform providers and the food and drug supervision and administration departments of network marketing enterprises and medical and pharmaceutical network transaction service providers may include their legal representative or principal responsible person in the list of dishonest enterprises and dereliction officers Open to the public.