On January 10, the State Administration for Market Regulation held a press briefing. A relevant official from the Medical Device Supervision Department of the Administration provided an interpretation and analysis of the key provisions of the newly promulgated Measures for the Supervision and Administration of Online Sales of Medical Devices (Order No. 38 of the Administration, hereinafter referred to as the “Measures”), as well as the regulatory landscape governing online medical device operations.

　　According to relevant officials, with the rapid growth of online medical device sales, problems such as the illegal sale of unregistered medical devices, false or exaggerated advertising, and consumer deception have been increasingly prevalent. For example, unauthorized sales of unregistered medical device products on e‑commerce platforms, official websites, or mobile apps, as well as the posting of unlawful or non‑compliant information, pose potential risks to public safety in the use of medical devices. At the same time, the virtual nature of online operations—characterized by cross‑jurisdictional reach, concealment, and ease of relocation—has given rise to issues such as unclear regulatory jurisdiction, outdated enforcement measures, difficulties in investigation and evidence collection, and a lack of adequate legal grounds for enforcement. Therefore, it is of great significance to refine the regulations governing online medical device sales and, at the institutional level, further clarify the principal responsibilities of online sellers and the oversight duties of regulators.

　　The General Administration, in accordance with the Cybersecurity Law, the Regulations on the Supervision and Administration of Medical Devices (hereinafter referred to as the “Regulations”), the Measures for the Administration of Internet Information Services, and other relevant laws and regulations, and taking into account the Opinions of the CPC Central Committee and the State Council on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices, as well as the practical realities of regulating online sales of medical devices, has formulated these Measures. The Measures comprise 50 articles, covering such matters as the legislative purpose, scope of application, obligations of enterprises engaged in online sales of medical devices and third-party platform providers of online trading services for medical devices, supervisory management, and legal liabilities.

　　Relevant officials emphasized that the Measures explicitly stipulate that the regulation of online sales of medical devices shall adhere to the principle of “consistency between online and offline.” Medical device manufacturers, operators, and marketing authorization holders engaged in online sales must ensure that their sales conditions comply with the requirements set forth in the Regulations and the Measures; meanwhile, third-party platform providers for online transactions are required to verify the business qualifications of enterprises registered on their platforms.

　　The Measures also require online sales enterprises and third-party platform providers of online trading services to file with the municipal bureau and the provincial bureau, respectively, and further specify the obligations of these entities. Specifically, online sales enterprises must ensure the quality and safety of medical devices; third-party platform providers are required to establish management systems for verifying and registering入驻 enterprises, monitoring quality and safety, and promptly suspending online trading services and reporting any illegal operators or illegal products. Moreover, both online sales enterprises and third-party platform providers must ensure that sales transaction data and related records are authentic, complete, and traceable.

　　With regard to the scope of online business operations for enterprises engaged in the online sale of medical devices, the Measures explicitly stipulate that such activities “shall not exceed the scope of their production and operation licenses or filings.” Wholesale enterprises engaging in the online sale of medical devices shall sell only to qualified medical device distributors or user institutions. Retail enterprises engaging in the online sale of medical devices shall sell only to individual consumers. Medical devices sold to individual consumers must be suitable for self‑use by the consumer, and their instructions must comply with relevant regulations on the management of medical device instructions and labels, including the inclusion of special notes on safe usage.

　　The Measures stipulate that the State Administration for Market Regulation shall establish a national online monitoring platform for medical devices and undertake nationwide monitoring and enforcement activities related to online sales and transactions of medical devices. According to relevant officials, the Administration began developing the national online monitoring platform for medical devices in 2016. The project is divided into three phases; to date, Phase I has been completed. During the platform’s trial‑run period, data were collected and monitored from major e‑commerce platforms as well as information service websites holding qualifications for providing internet-based pharmaceutical information services. Any illegal or non‑compliant information identified was promptly referred to the food and drug administration authorities of the relevant provinces, autonomous regions, and municipalities directly under the central government, thereby playing a positive role in the supervision and management of online medical device sales.

　　The quality and safety of medical devices sold online are matters of great public concern. According to the responsible official, the Measures strengthen risk control: when inspection reveals that an enterprise engaged in online sales of medical devices or a third-party platform provider has failed to establish and implement the required quality management systems, thereby posing risks to the quality and safety of medical devices, the regulatory authorities may order it to suspend online sales or to temporarily cease providing the relevant online trading services. In cases where quality and safety issues exist that could give rise to risks to the quality and safety of medical devices, the provincial and municipal bureaus may summon the legal representative or principal person in charge of the online seller or the third-party platform provider for a meeting. For online sellers and third-party platform providers that refuse to comply with orders to suspend online sales or to discontinue the relevant online trading services, or that fail to make required rectifications after being summoned, the food and drug regulatory authorities may place their legal representatives or principal persons in charge on lists of untrustworthy enterprises and individuals, and publicly disclose such information.

　　In addition, the Measures clarify that online information services for medical devices shall be governed by the Measures for the Administration of Internet Pharmaceutical Information Services. Relevant officials emphasized that enterprises engaging in the online sale of medical devices through their own websites, as well as third-party platforms providing medical device trading services, must obtain an Internet Pharmaceutical Information Service Qualification Certificate in accordance with the provisions of the Measures for the Administration of Internet Pharmaceutical Information Services.