The State Drug Administration convened a medical device network transaction management risk meeting

On June 14, the State Drug Administration held a chamber of commerce by the medical device network transaction management risk.

At the meeting, the Southern Medical Economics Research Institute of the State Drug Administration notified the recent medical device network transaction monitoring situation and the disposal of the clues of illegal and violations of the online transactions; The person in charge reported on the implementation of the main responsibility of the platform, the special rectification requirements of the State Drug Administration's drug safety, strengthened the management of network sales enterprises in the platform medical device, and standardized the online sales behavior of medical device online; the Beijing Pharmaceutical Regulatory Bureau, Shanghai Pharmaceuticals, Shanghai Pharmaceutical Bureau Relevant responsible comrades of the Supervision Bureau and Zhejiang Provincial Pharmaceutical Supervision Bureau reported on strengthening the supervision of medical device network transactions, strengthening dynamic monitoring of medical device network transactions, severely cracking down on illegal behaviors of medical device network transactions, improving the ability to prevent and control of network transactions in medical device, strengthen grassroots levels at the grassroots level The construction of supervision teams.

The meeting pointed out that in recent years, the State Drug Administration has continuously improved the construction of the regulatory regulations and regulations of medical device network transactions, deploying the local drug supervision departments to conduct in -depth medical device "Qingwang" operations and medical equipment quality and safety risks to investigate, and increase medical device network transactions Monitoring and illegal and illegal acts have continued to consolidate the main responsibility of the third -party platform of medical device network transaction services, and achieved certain results. Recently, the medical device network transaction monitoring has found that individual enterprises that settled in the platform have violations of laws and regulations. Relevant e -commerce platforms should attach great importance to it, carefully compare the requirements of laws, regulations and regulations, and carry out comprehensive self -investigation and rectification of e -commerce platforms to perform legal obligations.

The meeting requested that the third -party platform of medical device network transaction services must improve political standing and adhere to the people's supremacy. Taking strict implementation of the main responsibility of the platform and ensuring the quality and safety of the online sales of medical devices, it is used as a political task, internal management and personnel training are strengthened to ensure continuous compliance of online transaction services. Second, strict qualification review and strictly settle in the customs. Carefully checking the business license, registration certificate, and filing voucher information of the enterprise medical device business must be comprehensive, accurate, complete, and meticulous. If necessary, consult the issuance department and verify it. "Outside the door." Third, we must increase dynamic monitoring and timely dispose of reports of violations. We must continuously strengthen monitoring forces, innovate monitoring methods, strengthen the frequency and intensity of monitoring information on the network transaction information in the platform, and find that if the "Regulations on the Supervision and Administration of Medical Device" and "Measures for the Supervision and Administration of Medical Device Network Sales Supervision and Management" are found. Stopping measures such as online transaction services, and suspected illegal entry enterprises, report relevant clues to the drug regulatory authorities in time, and assist in providing relevant evidence materials to work together to do a good job of investigation and disposal of violations of laws and regulations.

The third -party platform of the participating medical device network transaction services stated that it will further improve the political standing, enhance the awareness of the rule of law, implement the main responsibility of the platform, continuously optimize the qualification audit system, increase the investment of professional audit personnel, improve the frequency of artificial inspections and the effectiveness of the audit, standardize the standards The market order in the network trading market in the platform, resolutely crack down on illegal activities of medical device network transactions, and effectively protect consumers' safety of equipment to buy equipment.

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