According to the website of the National Medical Products Administration on March 28th, on March 27th, the National Medical Products Administration held a forum for third-party platform enterprises in medical device online trading services to study and analyze the governance work of third-party platform enterprises in medical device online trading services, and put forward further requirements for fully implementing corporate main responsibility and territorial regulatory responsibility.
At the meeting, the Southern Office of the National Medical Products Administration reported on the monitoring and disposal of medical device network sales in 2022. The relevant principals of the drug administrations of Beijing, Shanghai, Jiangsu, Zhejiang, and Guangdong provinces (cities) reported on the monitoring of medical device network sales. Beijing Jingdong Sanbailiushidu E-commerce Co., Ltd., Shanghai Xunming Information Technology Co., Ltd., Shanghai Gewuzhipin Network Technology Co., Ltd Zhejiang Tmall Network Co., Ltd. conducts exchanges around the service management of third-party platforms for medical device online transactions.
The meeting fully affirmed the phased results achieved in the regulatory governance of medical device online sales. In recent years, the National Medical Products Administration has thoroughly implemented the decisions and arrangements of the Party Central Committee and the State Council, comprehensively strengthened the quality and safety supervision of medical devices throughout their life cycle, and has always included online sales as a key regulatory focus. Drug regulatory authorities at all levels conscientiously implement the "four strictest" requirements, highlight problem orientation, adhere to comprehensive policy implementation, improve regulatory systems, innovate regulatory methods, severely crack down on illegal acts, and strive to standardize the order of the online sales market of medical devices. Third-party platform enterprises continue to strengthen compliance construction, strengthen the construction of management teams, promote the innovative application of technical means, and continuously improve their management systems and capabilities. However, at the same time, some third-party platform enterprises still have problems in implementing the Regulations on the Supervision and Administration of Medical Devices and failing to fulfill their platform management responsibilities. For example, the qualification review of settled enterprises is not strict, the report on preventing illegal activities is not timely, and the provision of transaction services is not firm. It is necessary for third-party platform enterprises to seriously rectify with a high degree of responsibility for public health.
The meeting pointed out that creating a good ecological environment for online sales of medical devices requires the support of regulations, management technology, governance capabilities, and other support. It requires regulatory authorities and third-party platform enterprises to fully exert their initiative and creativity to jointly promote. The drug regulatory department will further improve the construction of relevant laws and regulations, and continuously improve more scientific, reasonable, and effective management systems and measures based on full research. Third-party platform enterprises should conduct in-depth self inspection and self correction for prominent issues reported at the meeting, draw inferences from one instance, continue to strengthen platform compliance construction, and effectively fulfill the main responsibilities of third-party platform enterprises.
The meeting emphasized that always bearing in mind that people's health is the "greatest of the country", effectively strengthening the governance of third-party platforms for medical device online trading services, and striving to effectively safeguard the public's health rights and interests with a clearer network ecological environment.
