This article is reproduced from the official website of the National Medical Products Administration.

Original link: https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20240710160448155.html

The National Medical Products Administration (NMPA) resolutely implements General Secretary Xi Jinping's "four strictest" requirements, focusing on the concerns of the people in the field of medical devices, innovating regulatory mechanisms, enriching regulatory methods, and continuously promoting the standardized governance of online sales of medical devices to effectively enhance the people's sense of security and gain in online medical device purchases.

　　Continuously strengthening the construction of laws and regulations. In recent years, the NMPA has strengthened the top-level design of regulations for the supervision of online sales of medical devices. In 2017, it issued the "Measures for the Supervision and Administration of Online Sales of Medical Devices," clarifying the relevant obligations and legal responsibilities of medical device online sales enterprises and third-party platforms providing online transaction services, and standardizing the online sales and transaction services of medical devices. In 2021, the "Regulations on the Supervision and Administration of Medical Devices" were revised, clarifying the management system for online sales of medical devices and further strengthening the supervision of online sales of medical devices.

　　Continuously innovating regulatory technical means. In view of the characteristics of online sales, such as virtuality, cross-regionality, and easy transfer, the NMPA has organized the construction of a monitoring platform for online sales of medical devices and simultaneously built an information flow closed-loop system for clue discovery, transfer and disposal, and result feedback. Continuously upgrading and improving the monitoring platform, promoting the vertical four-level supervision (national, provincial, municipal, and county) and horizontal cross-regional coordinated reporting and disposal mechanisms for illegal clues.

　　Continuously promoting a system of social co-governance. The NMPA deeply analyzes the characteristics and development trends of the online medical device market, organizes leading third-party platforms for online transactions of medical devices to establish a co-governance alliance for online sales safety risks, regularly reports on online sales of medical devices, public opinion monitoring, and complaints and reports, guides platform enterprises to carry out standardized governance, proactively identifies and resolves risks and hidden dangers, implements the main responsibilities of platform enterprises, and builds a pattern of social co-governance.

　　After years of continuous efforts, the illegal and irregular rate of online sales pages of medical devices has dropped from 3.2 per 100,000 in 2018 to 1.3 per 100,000 in 2023, effectively safeguarding the safety and legitimate rights and interests of the people's online purchase of medical devices and promoting the standardized, orderly, and high-quality development of the online sales market for medical devices.