State Food and Drug Administration meeting: strict inspection of medical equipment network sales


State Food and Drug Administration meeting: strict inspection of medical equipment network sales

Recently, the State Food and Drug Administration held a chamber of commerce for the management of medical device network trading risk.

Jingdong Mall, Pinduoduo Mall and Alibaba Group, three third-party platforms of online trading services for medical devices, were invited to attend the meeting and reported the management of online sales enterprises for medical devices on the platforms and the regulation of online sales behaviors for medical devices.

At the same time, the drug administration of Beijing, Shanghai and Zhejiang also reported the situation of strengthening the supervision of online trading of medical devices and strengthening the monitoring of online dynamic trading of medical devices.

The meeting pointed out that with the State Food and Drug Administration continuously improving the construction of regulations and regulations for online trading of medical devices in recent years, and the "clean network" campaign carried out across the country, the crackdown on illegal activities of online trading of medical devices has achieved some results.

The meeting also put forward three requirements for the third party platform of medical device online trading service:

First, it requires the third party platform of medical device online trading service. First, it should raise the political position and insist that the people come first. The second is to strictly check the qualification, strictly enter the gate; Third, we should increase dynamic monitoring and timely deal with violations reported.

It is worth noting that Jingdong Health and Alibaba have attended the "Medical Device online Sales Supervision Work Exchange Meeting" held by the State Food and Drug Administration for many times.

Obviously, the state is further strengthening the supervision of online sales of medical devices. In addition, the concentration of online sales channels of medical devices is gradually strengthening, and the header Internet platform has become the focus of the zhong point of the drug regulatory system.

Big players are coming in

The state further strengthened the supervision of the platform

In recent years, in addition to the three platforms mentioned above, JD.com, Ali and Pinduoduo, more and more giant enterprises have also joined this "battlefield".

At the beginning of 2018, Douyin launched columns such as "shopping cart" and "commodity window". Similar to Meituan and Ele. me, Douyin selected healthcare products with consumer attributes such as massage instrument and test paper.

After that, Douyin E-commerce issued a public Notice on the Newly Added Category Management Norms of [Medical Devices] this year, officially entering the bureau of e-commerce medical devices.

With the continuous expansion of the online sales platform of medical devices, there are also a number of domestic medical devices and other fields focused on this market. Earlier, some companies also began to look for "loopholes" in the online sales platforms of medical devices due to incomplete regulatory measures.

In August 2021, Shanghai Food and Drug Administration issued an announcement saying that from September 2019 to July 2020, Dive Medical violated the Measures for the Supervision and Administration of Online Sales of Medical Devices for several times. On the page of Dive Shanghai Store on Taobao platform, there were problems such as not changing the record information and not displaying the registration certificate of medical devices. The Shanghai Food and Drug Administration gave the company a warning.

In addition, taking a local drug administration as an example, according to the national medical device online transaction monitoring platform, more than 60% of the illegal clues involving medical device enterprises within the jurisdiction were provided by Pinduoduo, Jingdong, Taobao/Tmall, wechat and other four platforms.

This is also the State Food and Drug Administration continues to strengthen the attention of the head Internet platform.

In recent years, the number of third-party platforms for medical device online trading services has increased year by year. According to incomplete statistics, from December 2018 to June 2021, the number of third-party platform filings for medical device online trading services increased from 57 to 429.

With the continuous implementation of the "network cleaning" action, local drug supervision and administration departments are also intensifying the rectification of platform enterprises, strengthening the supervision of platform enterprises through interviews and ordering rectification, repeatedly emphasizing that platforms should fulfill the obligations of real-name registration, qualification examination, business behavior management and other obligations of operators of medical devices entering the network, and carry out regular self-examination and self-correction.

The gradual standardization of online sales of medical devices is a huge challenge for both e-commerce platforms and medical equipment enterprises.

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What is a medical device

Medical instruments refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles, including required computer software, which are directly or indirectly used in human body.


History of medical device development

Medical device industry involves medicine, machinery, electronics, plastics and other industries, is a multidisciplinary, knowledge-intensive, capital-intensive high-tech industry. The basic characteristics of high-tech medical equipment are digitalization and computerization, and it is the crystallization of modern high technology of multi-disciplines and cross-fields. Its products have high technology content and high profit, so it is the top point of competition among major scientific and technological countries and large international companies, and the threshold of entry is high. Even in the industry overall gross profit rate is low, investment is not high sub-industries will continue to have higher technology products, and from which some enterprises with strong profitability. Therefore, the overall trend of the industry is high investment, high yield.


State Food and Drug Administration meeting: strict inspection of medical equipment network sales

Recently, the State Food and Drug Administration held a chamber of commerce for the management of medical device network trading risk.


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