I. Background of the formulation of the Quality Management Specifications for Online Sales of Medical Devices (hereinafter referred to as the Specifications)

With the rapid development of e-commerce, the online medical device sales market in China has experienced explosive growth in recent years. According to statistics, from 2018 to the present, the number of medical device distributors engaged in online sales has increased from 8,717 to over 360,000, while the number of third-party platform enterprises has grown from 77 to 851.

The NMPA has always attached great importance to the quality and safety of medical device online sales, continuously improving the relevant regulations for online sales of medical devices. The relevant provisions on online sales have been incorporated into the newly revised Regulations for the Supervision and Administration of Medical Devices, and the Measures on the Supervision and Administration of Online Sales of Medical Devices have been issued and implemented to promote the healthy and orderly development of the online medical device market.

With the continuous deepening of regulatory efforts, local drug regulatory authorities and enterprises have reflected that there is a lack of unified normative guidance in practice, and there is an urgent need to formulate practical, scientific, effective, and operable normative requirements to guide enterprises in better fulfilling their principal responsibilities and promoting the healthy development of the industry.

II. Overall Approach and Main Content of the Specifications

As an important normative document to guide the quality management as well as supervision and administration of online sales of medical devices, the Specifications focus on four key principles in its overall approach: First, upholding and implementing the requirements of laws and regulations. The Specifications were drafted in accordance with relevant laws, administrative regulations, and departmental rules, including the E-Commerce Law of the People's Republic of China, the Regulations for the Supervision and Administration of Medical Devices, the Measures on the Supervision and Administration of Online Sales of Medical Devices, and the Provisions for Supervision and Administration of Medical Device Distribution. Second, ensuring the fulfillment of the primary responsibilities by enterprises. By refining management norms, the Specifications specify that the online sales operators and platform operators of medical devices should earnestly fulfill their social responsibilities and obligations, proactively strengthen quality risk prevention and control, and ensure the quality and safety of medical devices sold through online channels. Third, summarizing and building on regulatory practice and experience. The content of the Specifications is closely aligned with the newly revised Good Supply Practice for Medical Devices and incorporates beneficial practices and experiences from local regulatory authorities in the supervision and management of online sales of medical devices, proposing effective and actionable quality management requirements for online sales. Fourth, extensively listening to and responding to industry demands. The drafting process involved broad consultation with stakeholders in the industry to better understand the challenges encountered in online sales quality management. It aimed to proactively identify and address the urgent needs and expectations of enterprises, promote innovative regulatory approaches, and implement the "Streamline Administration, Delegate Power, Strengthen Regulation and Improve Services" reform. While safeguarding quality and safety, the Specifications seek to meaningfully respond to industry concerns, resolve pain points, and unleash market innovation vitality.

The Specifications consist of four chapters and fifty articles, divided into General Provisions, Quality Management for Online Sales Operators, Quality Management for E-commerce Platform Operators, and Supplementary Provisions. The Specifications establish the basic requirements that online sales operators and e-commerce platform operators should, in accordance with the provisions herein, establish and improve a quality management system suited to the online sales of medical devices and ensure its effective operation.

III. Relationship between the Specifications and the Good Supply Practice for Medical Devices

The Quality Management Specifications for Online Sales of Medical Devices and the Good Supply Practice for Medical Devices are complementary in content and parallel in legal status, serving as two normative documents at the same regulatory level.

Online sales of medical devices represent a specialized business model under the broader category of medical device distribution. Enterprises engaged in such activities must first comply with applicable laws, administrative regulations, and normative documents, including the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Supervision and Administration of Medical Device Distribution, and the Good Supply Practice for Medical Devices.

Article 46 of the Regulations for the Supervision and Administration of Medical Devices clearly stipulates that entities engaging in the online sales of medical devices should be either medical device registrants, filers, or licensed medical device distributors. Therefore, the Specifications propose quality management requirements for various aspects of online sales operators, such as the responsibilities of quality management departments, staffing, quality system documentation, incoming inspection, and sales/purchase records based on the requirements of the Good Supply Practice for Medical Devices, while taking into account the characteristics of online distribution.

IV. In what aspects does the Specifications further reinforce the responsibilities of online sales operators?

The Specifications strictly implement the provisions and requirements of laws, regulations, and normative documents, including the E-Commerce Law of the People's Republic of China, the Regulations for the Supervision and Administration of Medical Devices, the Provisions for Supervision and Administration of Medical Device Distribution, and the Measures on the Supervision and Administration of Online Sales of Medical Devices. First, establish a quality management system for online sales of medical devices. The Specifications guide online sales operators to establish and improve a quality management system suited to online sales of medical devices, including refining the responsibilities of quality management departments, enriching the content of personnel training, improving the formulation of system documents, and clarifying requirements for system self-inspections. Second, strengthen guidelines for quality management of online sales. The Specifications guide online sales operators to standardize quality management practices for online sales, including legally displaying enterprise qualification information and product information, maintaining complete online sales records and relevant supporting documents, and taking effective measures to ensure product quality and safety during transportation. Third, promote online sales operators to strengthen risk management. The Specifications require that, upon identifying any product quality issues or potential safety risks, online medical device sales operators should take risk control measures in accordance with the law, such as suspending the display of product information or suspending sales, when quality issues or potential safety hazards are identified in their products.

V. What are the requirements of the Specifications regarding the public disclosure of business entity information?

Article 15 of the E-Commerce Law of the People's Republic of China clearly requires that e-commerce operators prominently and continuously disclose their business license information and administrative licensing information related to their business operations on the homepage of their platforms. The Specifications implement the registrant and filing entity system for medical devices and set forth public disclosure requirements for enterprise entity information under three distinct circumstances: For medical device distributors that have obtained a distribution license or completed filing procedures, they should publicly display their Medical Device Business License or Class II Medical Device Distribution Filing Certificate; For medical device registrants that have obtained a manufacturing license, they should publicly display their Medical Device Manufacturing License; For medical device registrants that outsource production to other enterprises, they should publicly display the Medical Device Registration Certificate. The relevant certificates and credentials may be disclosed using images or links to the corresponding electronic certificates, and certificate or credential numbers should be displayed in text format.

VI. Are there any special requirements for the sale of medical devices, such as contact lenses and hearing aids, that require specific fitting?

Medical devices such as contact lenses and hearing aids should undergo professional fitting, adjustment, or trial use prior to being used. The fitting process should ensure that the product meets the individual needs of the user, thereby minimizing discomfort and potential risks during use.

According to Article 17 of the E-commerce Law of the People's Republic of China, e-commerce operators should comprehensively, truthfully, accurately, and promptly disclose product or service information to safeguard consumers' right to know and right to choose.

In view of the characteristics of these products, the Specifications require that for online sales of medical devices such as contact lenses and hearing aids that require specific fitting, online sales operators should prominently and continuously display the following warning messages on the product page, such as "Professional fitting by an eyecare professional is required prior to using this product" and “Prior to hearing aid fitting, professional examination and hearing tests are required. The product should be used under the adjustment, trial fitting, and guidance of a licensed hearing aid fitting professional.”

VII. In what aspects do the Specifications further strengthen the responsibilities of e-commerce platform operators?

The Measures on Supervision and Administration of Online Sales of Medical Devices establish fundamental requirements for e-commerce platform operators in terms of office space, technical conditions, the establishment of management institutions and personnel, as well as the formulation and implementation of quality management systems. Building upon these requirements, the Specifications further refine and strengthen the management responsibilities of e-commerce platform operators. Firstly, it clarifies the quality and safety management responsibilities of e-commerce platform operators. E-commerce platform operators should conduct real-name registration of all onboarded online sales operators and review their relevant medical device licenses, filings, as well as the registration and filing status of medical devices sold online. The operators should take effective measures to supervise and manage the business activities of medical device operators on the platform. Secondly, it guides e-commerce platform operators in establishing and improving their quality management systems. It clarifies the responsibilities of the quality management institutions and personnel of e-commerce platform operators, refines the functions of the online trading system, improves the system documents covering the entire process of medical device online trading services, and guides e-commerce platform operators in conducting quality management system audits, corrections, and prevention to ensure the effective operation and continuous improvement of the quality management system. Thirdly, it guides e-commerce platform operators in safeguarding the legitimate rights and interests of consumers in accordance with the law. It clarifies that e-commerce platform operators should establish a complaint and reporting management system, publicly disclose information such as complaint and reporting channels, urge online sales operators on the platform to investigate the causes of reported medical device quality and safety issues, take effective measures to handle and provide feedback, and maintain relevant records promptly. When necessary, the e-commerce platform operators should proactively investigate and handle complaints related to medical device quality and safety issues.

VIII. What are the special requirements of the Specifications for e-commerce platform operators in terms of personnel allocation and organizational structure?

In terms of personnel allocation, the Specifications adhere to the principle of "people-oriented" and focus on key personnel, clarifying that the legal representative or principal responsible person of e-commerce platform operators should be fully responsible for the quality and safety of medical devices sold online. It specifies that the person responsible for quality and safety management should be responsible for the quality and safety management of online sales of medical devices, assume corresponding quality and safety management responsibilities, and have the adjudicative right to make decisions on medical device quality and safety management within the enterprise. It requires that the legal representatives, principal responsible persons, and quality and safety management personnel of e-commerce platform operators should be familiar with the requirements of laws, regulations, rules, and specifications, and should not be engaged in prohibited activities as stipulated in relevant laws and regulations.

In terms of organizational structure, the Specifications require that e-commerce platform operators should establish a medical device quality and safety management institution that is commensurate with the scale of medical device online trading services and the level of risk associated with the medical devices involved, and clarify the responsibilities of the institution. For those who have not established a quality and safety management institution, they should designate dedicated medical device quality and safety management personnel to fulfill the responsibilities of the quality and safety management institution.

IX. How should e-commerce platform operators handle violations committed by online sales operators on their platforms?

The Specifications require that e-commerce platform operators should establish a system for detecting and handling violations of laws and regulations in the online sales of medical devices on their platforms. If they discover that an online sales operator on the platform has failed to display the qualification information of the business entity or product information as required, they should demand that the online sales operator immediately make corrections and record the violation and the rectification. If the sales operator fails to make corrections as required, the platform operator should immediately report to the drug regulatory department at the level of the municipality where the online sales operator is located.

In cases where the platform operator suspects that an online sales operator may be engaging in serious violations—such as selling medical devices without obtaining the necessary licenses or filings, selling unregistered or unfiled medical devices, operating beyond the approved scope of licenses or filings, or selling medical devices that have been publicly prohibited from sale or use by the drug regulatory department, the platform operator should immediately cease providing relevant online trading services, remove associated product information from display, and report to the drug regulatory department at the level of the municipality where the online sales operator is located.

X. How should e-commerce platform operators continuously strengthen the risk management of medical device quality and safety?

The Specifications guide e-commerce platform operators to continuously strengthen the risk management of medical device quality and safety by enhancing internal risk monitoring and collecting and analyzing external risk information. The document also outlines a pathway and key indicators for enterprises to follow in strengthening such risk management.

Firstly, regarding the implementation of responsibilities for personnel in key positions, the Specifications clarify that the legal representative or principal responsible person of the e-commerce platform should conduct at least one quarterly work consultation and summary on the quality and safety risks of medical device online sales on the platform, thereby reinforcing the responsibilities of key personnel. Secondly, the Specifications guide e-commerce platform operators to strengthen internal monitoring of medical device quality and safety risks through methods such as analyzing purchaser complaints and conducting quality inspections. At the same time, the Specifications require that e-commerce platform operators should actively pay attention to and collect regulatory dynamic information such as medical device supervision and inspection, administrative penalties, supervisory sampling inspections, and product recalls published on the website of the drug regulatory department, and promptly conduct self-inspections. Enterprises are required to take timely risk control measures in response to product quality and safety risks identified through monitoring and self-inspection, including internal rectification, suspension of product information release, suspension of sales, cessation of online trading services, and reporting to regulatory authorities, in order to comprehensively strengthen the management of medical device quality and safety risks.