State Drug Administration meeting: strict investigation of medical machinery online sales

　　Recently, the State Drug Administration held a medical device network trading management risk meeting.

　　Jingdong Mall, Jindo Mall, Alibaba Group, the three medical device network trading services third-party platform was invited to participate in the meeting, reported on the management of medical device network sales enterprises stationed on the platform, regulate the medical device network sales behavior and other aspects.

　　At the same time, Beijing, Shanghai, Zhejiang, the three Drug Administration also reported to strengthen the supervision of medical device network transactions, strengthen the monitoring of dynamic medical device network transactions.

　　The meeting pointed out that, with the State Drug Administration in recent years to continuously improve the medical device network trading regulation and system construction, and around the country to carry out the "clean network" action to combat medical device network trading violations have achieved certain results.

　　The meeting also put forward three major requirements for medical device network trading services third-party platform: First, the requirements of medical device network trading services third-party platform.

　　First, the requirements of medical device network trading services third-party platform one to raise the political stance, adhere to the people first; second, to strict qualification audit, strict entry level; third, to increase dynamic monitoring, timely disposal of the report violations.

　　It is worth noting that the State Drug Administration held several times before the "medical device network sales supervision and exchange of work", Jingdong Health and Alibaba each time are present.

　　Obviously, the state is further strengthening the supervision of medical device network sales. And the concentration of medical device network sales channels is gradually strengthening, the head of the Internet platform has become the zhong point of attention of the drug regulatory system.

　　Giants have entered the game

　　The state further strengthens the supervision of the platform

　　In recent years, in addition to the above-mentioned Jingdong, Ali, Jindo the three major platforms, more and more giant companies have joined this "battlefield".

　　In early 2018, Jitterbug had online "shopping cart" "commodity window" and other columns, and Meituan, hungry and other platforms similar to Jitterbug choose massage instrument, test strips and other consumer attributes of health care products.

　　After that, Jitterbug e-commerce released this year, "on the new <[medical device] category management specification" notice of public notice, the official entry into the e-commerce medical devices.

　　With the continuous expansion of medical device network sales platforms, there are also many mechanical enterprises focusing on areas such as home medical devices eyeing this market. Earlier, because the regulatory means has not been perfect, some companies also began to look for "loopholes" from the medical device network sales platform.

　　In August 2021, the Shanghai Drug Administration issued a notice stating that from September 2019 to July 2020, Yuyue Medical had violated the Supervision and Administration of Medical Device Network Sales several times by not changing the record information and not displaying the medical device registration certificate on the page of "Yuyue Shanghai Store" on Taobao platform. The Shanghai Pharmacovigilance Bureau issued warnings and penalties.

　　In addition, according to the national medical device network trading monitoring platform, more than 60% of the clues involving medical device enterprises in the jurisdiction are provided by the 4 major platforms, such as Jindo, Jingdong, Taobao/Tmall and WeChat, for example.

　　This is precisely the reason why the State Drug Administration continues to strengthen its focus on the head Internet platform.

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

　　And with the "clear network" action continues to land, the local drug supervision and management departments are also increasing the remediation of the platform enterprises, through interviews, and order rectification to strengthen the supervision of the platform enterprises, repeatedly stressed that the platform to fulfill the real name registration of medical device operators on the network, qualification review, management of business practices and other obligations, and regularly carry out Self-investigation and self-correction.

　　The gradual standardization of online sales of medical devices, whether for the e-commerce platform or medical machinery enterprises, is a huge challenge.