The order of online sales of medical devices is gradually standardized, and the “net cleaning” action of medical devices has achieved remarkable results

Medical Network, July 23, July 21, one of the key activities of the 2021 "National Medical Device Safety Publicity Week"-Medical Device Online Sales Supervision Symposium was held in Beijing to promote the supervision and management of medical device online sales.
Order of online medical device transactions
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The reporter learned at the meeting that while the online sales of medical devices improve people's livelihood and provide convenience, the quality and safety of online sales of medical devices also brings new challenges to the supervision work
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Due to the virtuality, cross-regional nature, concealment, and easy transferability of the Internet, it is difficult to detect illegal activities in the online sales of medical devices, difficult to determine the subject of the illegal, difficult to define territorial responsibility, and difficult to fix illegal evidence, which brings supervision to the work.
Difficulties and challenges come
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The meeting pointed out that the supervision of online sales of medical devices is an important part of establishing a sound, scientific, efficient and authoritative drug supervision system
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In recent years, the State Food and Drug Administration has continuously improved the regulations on online sales of medical devices , organized the formulation of the “Measures for the Supervision and Administration of Online Sales of Medical Devices”, and incorporated relevant regulations on online sales into the newly revised “Regulations on the Supervision and Administration of Medical Devices” to further clarify the medical treatment Obligations and responsibilities of e-commerce operators and platform operators in equipment network transactions
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The State Food and Drug Administration adheres to the principle of “consistent online and offline”, focuses on the problems existing in third-party platforms of medical device online transaction services, online sales companies , medical device products, and online sales information, and organizes a nationwide “cleaning network” of medical devices Action
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In addition, in order to strengthen the supervision of online sales of medical devices, in 2017, the State Food and Drug Administration organized the construction of the "Medical Device Online Transaction Monitoring Platform" project
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At present, the monitoring platform has covered more than 400 prefectures and cities in 31 provinces, opened more than 600 supervision accounts, realized the vertical linkage of the national bureau, the provincial bureau, and the municipal bureau, and horizontally realized the discovery, disposal and treatment of illegal and illegal information on online sales among various provinces.
Timely and efficient circulation of feedback
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It is understood that the number of third-party platforms for medical device online transaction services is increasing year by year
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According to incomplete statistics, from December 2018 to June 2021, the number of third-party platforms for medical device online transaction services increased from 57 to 429, and the enthusiasm for participation of medical device market entities was high
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Since the launch of the "Clear Network" action, local drug regulatory authorities have increased the rectification of platform companies, strengthened the supervision of platform companies through interviews, ordered rectification and other methods, and the online sales access has gradually been standardized
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The meeting emphasized that third-party platform companies for medical device online transaction services should attach great importance to the management of medical device online transaction services, and earnestly perform the obligations of real-name registration, qualification review, and business behavior management for networked medical device operators, in accordance with the quality and safety of medical devices The investigation and management of hidden dangers requires serious self-examination and self-correction
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Local drug regulatory authorities should continue to carry out in-depth investigation and management of medical device quality and safety risks, continue to carry out the "cleaning network" action of medical devices, focus on key products such as epidemic prevention and control medical devices, and intensify the monitoring and supervision and inspection of the network of platform enterprises.
Strictly investigate and deal with violations of laws and regulations discovered in accordance with the law
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Through the investigation and management of hidden risks, promote the implementation of the newly revised "Regulations on the Supervision and Administration of Medical Devices", further consolidate the management responsibilities of platform companies, supervise platform companies to perform statutory obligations, and provide medical device online transaction services in strict accordance with laws and regulations
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