On June 14, the State Food and Drug Administration held a risk meeting on the management of medical device online transactions.
At the meeting, the Southern Medical Economics Research Institute of the State Food and Drug Administration reported the recent monitoring of online transactions of medical devices and the handling of clues to illegal online transactions; Jingdong Mall, Pinduoduo Mall, and Alibaba Group are three third-party platforms for online transaction services of medical devices. The person in charge reported on the implementation of the main responsibilities of the platform, the implementation of the special rectification requirements for drug safety of the State Food and Drug Administration, the strengthening of the management of online medical device sales enterprises that have entered the platform, and the standardization of online sales of medical devices. The relevant responsible comrades of the Supervision Bureau and the Zhejiang Provincial Food and Drug Administration reported on strengthening the supervision of medical device online transactions, strengthening the dynamic monitoring of medical device online transactions, severely cracking down on violations of laws and regulations in medical device online transactions, improving the risk prevention and control capabilities of medical device online transactions, and strengthening grassroots Supervising team building, etc.
The meeting pointed out that in recent years, the State Food and Drug Administration has continuously improved the construction of regulations and systems for the supervision of online medical device transactions, deployed local drug regulatory departments to carry out in-depth medical device "cleaning up" actions and the investigation of potential risks of medical device quality and safety, and increased online medical device transactions. The monitoring and crackdown on violations of laws and regulations have been strengthened, and the main responsibility of the third-party platform for medical device online transaction services has been continuously consolidated, and certain results have been achieved. The recent monitoring of online transactions of medical devices has found that some companies that have entered the platform have violations of laws and regulations. Relevant e-commerce platforms should attach great importance to them, carefully check the requirements of laws, regulations and rules, and conduct comprehensive self-examination and rectification of the e-commerce platforms' fulfillment of legal obligations.
The meeting demanded that the third-party platform for medical device online transaction services must improve its political position and adhere to the supremacy of the people. Strictly implement the main responsibility of the platform and ensure the quality and safety of medical device online sales as a political task, strengthen internal management and personnel training, and ensure continuous compliance of online transaction services. Second, we must strictly review the qualifications and strictly control the entry. Carefully check the information of the medical device business license, registration certificate and filing certificate of the settled enterprise, and be sure to be comprehensive, accurate, complete and meticulous. If necessary, consult and verify with the license issuing department. outside the door". Third, we must increase dynamic monitoring and promptly handle and report violations. It is necessary to continuously strengthen the monitoring force, innovate the monitoring methods, strengthen the monitoring frequency and intensity of the online transaction information of medical devices on the platform, and find violations of the "Regulations on the Supervision and Administration of Medical Devices", "Measures for the Supervision and Administration of Online Sales of Medical Devices" and other regulations, should be taken immediately. Stop online transaction services and other measures, and report relevant clues to the drug regulatory department in a timely manner for the settled enterprises suspected of violations of laws and regulations, and assist in providing relevant evidence materials, and coordinate the investigation and disposal of violations of laws and regulations.
The third-party platform for medical device online trading services said that it will further improve its political position, enhance the awareness of the rule of law, implement the main responsibility of the platform, continuously optimize the qualification review system, increase the investment of professional reviewers, increase the frequency of manual inspections and review efficiency, and standardize The order of the medical device online trading market on the platform, resolutely crack down on illegal and illegal acts of medical device online trading, and effectively ensure the safety of consumers purchasing and using equipment.