To strengthen the supervision and administration of online sales of medical devices and online trading services for medical devices, and to ensure public safety in the use of medical devices, the State Food and Drug Administration has formulated and promulgated the Measures for the Supervision and Administration of Online Sales of Medical Devices (hereinafter referred to as the “Measures”), which will come into effect on March 1, 2018. The following is an interpretation of relevant issues:

　　 I. Why was the Measures formulated?

　　As the “Internet Plus” initiative continues to advance, the integration of the medical device industry with the internet is accelerating, and online sales of medical devices are becoming increasingly active. In recent years, the state has successively introduced a series of policies aimed at further reducing institutional and systemic barriers that constrain the development of e‑commerce. At the same time, problems such as the online sale of counterfeit or substandard medical devices, false or exaggerated advertising, and consumer deception have continued to emerge. For example, unauthorized sales of unregistered medical device products on e‑commerce platforms, official websites, or mobile apps, as well as the posting of illegal or non‑compliant information, have become frequent occurrences, posing potential risks to public safety in the use of medical devices. Moreover, due to the virtual, cross‑regional, concealed, and easily transferable nature of online sales, numerous challenges have arisen, including unclear regulatory jurisdiction, outdated supervisory measures, difficulties in investigation and evidence collection, and a lack of adequate legal grounds for enforcement. Therefore, it is of great significance to improve the regulations governing online sales of medical devices, clearly defining at the institutional level the responsibilities of market entities and regulatory authorities, thereby strengthening oversight mechanisms and measures, continuously standardizing business practices, and rigorously cracking down on violations in the online sale of medical devices. Accordingly, in accordance with the Cybersecurity Law, the Regulations on the Supervision and Administration of Medical Devices, and other relevant laws and regulations, and taking into account the Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices, as well as the practical needs of regulating online medical device sales, the National Medical Products Administration has formulated these Measures. The Measures comprise fifty articles, covering the legislative purpose, scope of application, obligations of enterprises engaged in online sales of medical devices and third‑party platform providers of online medical device trading services, as well as provisions on supervision, administration, and legal liability.

　　 II. What is the difference between “enterprises engaged in the online sale of medical devices” and “third-party platform providers for online medical device trading” as referred to in these Measures?

　　The Measures explicitly establish the principle of “consistency between online and offline operations.” Enterprises engaged in the online sale of medical devices must be legally authorized entities—either manufacturers or distributors holding a valid medical device manufacturing license, a business license, or having completed the required filing—or marketing authorization holders (i.e., registrants or filers) whose sales conditions comply with the requirements set forth in the Regulations on the Supervision and Administration of Medical Devices and these Measures. Their operational model entails selling medical devices through either their own self-built websites (including web‑based client applications) or third‑party platforms providing online trading services for medical devices.
　　A third-party platform provider for online medical device trading refers to an entity that, in the context of online medical device transactions, provides only services such as web space, virtual trading venues, transaction rules, transaction matching, and electronic orders, enabling two or more parties to conduct trading activities, without directly engaging in the sale of medical devices.
　　In addition, the Measures explicitly stipulate that online information services for medical devices shall be governed by the Measures for the Administration of Internet Pharmaceutical Information Services. Accordingly, enterprises engaging in the online sale of medical devices through their own websites, as well as third-party platform providers of online trading services for medical devices, must obtain an Internet Pharmaceutical Information Service Qualification Certificate in accordance with the Measures for the Administration of Internet Pharmaceutical Information Services.

　　 III. What are the principal obligations imposed by the Measures on enterprises engaged in the online sale of medical devices and on third-party platform providers of online medical device trading services?

　　First, fulfill the filing obligation. Enterprises engaged in the online sale of medical devices shall file with the municipal-level food and drug administration department where they are located; if any relevant information changes, they shall promptly update their filing. Third-party platform providers of online medical device trading services shall file with the provincial-level food and drug administration department where they are located; if any related filing information changes, they shall promptly amend their filing.
　　Second, establish systems related to medical device quality management. Third-party platform providers for online trading of medical devices shall formulate and implement management systems covering the verification and registration of medical device manufacturers and operators entering the platform, quality and safety monitoring, transaction security safeguards, prevention and reporting of illegal online sales activities, suspension of platform services in cases of serious violations, handling of safety-related complaints and reports, protection of consumer rights, and public disclosure of quality and safety information.
　　Third, the obligation to review and register. Providers of third-party online trading platforms for medical devices shall verify and register the documents submitted by medical device manufacturers and operators seeking to join the platform, including their medical device manufacturing and operation licenses or filing certificates, medical device registration certificates or filing certificates, and business licenses, establish relevant records and update them promptly, and enter into entry agreements with such entities, clearly specifying the obligations of both parties as well as measures for handling breaches of contract and other related matters.
　　Fourth, the relevant requirements regarding qualifications, premises, technical capabilities, and management personnel. Enterprises engaged in the online sale of medical devices and third-party online trading platform providers for medical devices shall, in accordance with the law, obtain an Internet Pharmaceutical Information Service Qualification Certificate, possess office premises commensurate with their scale, and have the requisite technical capabilities for data backup, fault recovery, and other functions. They must also establish a dedicated organization responsible for the quality and safety management of medical devices sold online or appoint qualified personnel to oversee such matters.
　　Fifth, platform management obligations. Third-party providers of online medical device trading platforms shall monitor the sales activities and information posted on their platforms. If they discover that a medical device manufacturer or operator registered on the platform has engaged in illegal conduct, they shall immediately suspend its online trading services, retain relevant records, and report the matter to the provincial food and drug administration authority where the platform is located. Furthermore, if such a manufacturer or operator is ordered by the food and drug administration to cease production and business operations, have its license revoked, or face other similar penalties, the platform provider shall promptly terminate its online trading services for that entity.
　　Sixth, the obligation to maintain records. Enterprises engaged in the online sale of medical devices and third-party online trading platform providers for medical devices shall keep records of medical device transaction information. Such records shall be retained for two years after the expiration date of the medical device; if no expiration date is specified, the retention period shall be no less than five years. Transaction information pertaining to implantable medical devices shall be preserved permanently. Appropriate technical measures shall be implemented to ensure that online sales data and related materials are authentic, complete, secure, and traceable.

　　 IV. What is the scope of online business operations for enterprises engaged in the online sale of medical devices as stipulated in the Measures?

　　The scope of online business operations for medical devices shall not exceed the scope authorized by 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 conducting online sales of medical devices shall sell exclusively to individual consumers. Medical devices sold to individual consumers must be intended for self‑use by the consumer, and their instructions must comply with relevant regulations on the management of medical device instructions and labeling, including clear markings of special precautions for safe use. Medical devices intended for use in healthcare facilities may not be sold to individuals.

　　 V. Requirements under the Measures for the Storage and Distribution of Medical Devices Sold Online.

　　Enterprises engaged in the online sale of medical devices shall store and transport such devices in accordance with the conditions specified on the device labels and in the instructions. When entrusting another entity with the storage and transportation of medical devices, they shall assess and evaluate the entrusted party’s capability to ensure the quality of storage and transportation, clearly define quality responsibilities throughout the storage and transportation processes, and thereby guarantee the safety and quality of the devices during these processes.

　　 VI. Allocation of Responsibilities Among Food and Drug Regulatory Authorities at All Levels under the Measures.

　　The National Medical Products Administration is responsible for guiding the supervision and administration of online medical device sales and third-party platforms providing online trading services for medical devices nationwide, and for organizing and conducting nationwide monitoring of online medical device sales. Provincial-level food and drug administration departments are responsible for the supervision and administration of third-party platforms offering online trading services for medical devices. Local food and drug administration departments at or above the county level are responsible for the supervision and administration of online medical device sales within their respective administrative jurisdictions.

　　 VII. Measures for the Prevention and Control of Quality and Safety Risks in Online Sales of Medical Devices under these Measures.

　　If, during an inspection, the food and drug administration finds that an enterprise engaged in the online sale of medical devices or a third-party platform providing online trading services for medical devices has failed to establish and implement the relevant quality management systems as required, and that such failure poses risks to the quality and safety of medical devices, it may order the entity to suspend online sales or to temporarily cease providing the relevant online trading services.
　　Where it is discovered that an enterprise engaged in the online sale of medical devices or a third-party platform providing online trading services for medical devices has issues concerning the quality and safety of medical devices that may give rise to risks to such quality and safety, the competent authority may, in accordance with its duties, summon the legal representative or principal person in charge for a discussion.
　　Furthermore, with respect to medical devices that cause harm to human health or for which there is evidence suggesting they may pose a risk to human health, the Regulations on the Supervision and Administration of Medical Devices explicitly provide that the food and drug administration authorities may impose emergency control measures, including suspending production, importation, distribution, and use.

　　 VIII. The Measures set forth disciplinary measures against the principal persons in charge of medical device online sales enterprises and third-party platform providers of medical device online trading services that engage in illegal or non-compliant activities.

　　The Measures not only clarify the legal liabilities of medical device online sales enterprises and third-party platform providers of medical device online trading services, but also prescribe disciplinary measures for the relevant persons in charge. For online sales enterprises and third-party platform providers of medical device online trading services that refuse to comply with orders to suspend online sales or the provision of related online trading services, or that, after being summoned for a meeting, fail to make rectifications as required, the food and drug administration authorities may include their legal representatives or principal persons in charge on lists of untrustworthy enterprises and untrustworthy individuals, and make such listings public.