New Rules Explained! Major Changes Coming to Online Sales of Medical Devices

On April 28th, the National Medical Products Administration released a significant document – the “Quality Management Specifications for the Online Sale of Medical Devices” (hereinafter referred to as the “Specifications”), which will come into effect on October 1st, 2025. What are the special features of this specification? And what changes will it bring to the industry?

Ⅰ. Why is the Specifications introduced?

From 2018 to the present, the number of medical device business enterprises engaged in online sales has skyrocketed from 8,717 to more than 360,000, like a rocket. The number of third – party platform enterprises has also increased from 77 to 851. While the market scale is expanding rapidly, the quality and safety issues of online sales of medical devices have received increasing attention.

Ⅱ. Closely adhere to the four principles and lay the cornerstone of industry norms

As an important document guiding the quality management and supervision of the online sales of medical devices, the “Specification” adhered firmly to four principles during its formulation:

i.Regulations come first, and there are laws to abide by.

Based on the “Electronic Commerce Law of the People’s Republic of China”, “Regulations on the Supervision and Administration of Medical Devices”, “Measures for Supervision and Administration of the Online Sale of Medical Devices”, “Measures for Supervision and Administration of the Business Operation of Medical Devices” and other relevant laws, regulations and departmental rules, the drafting of the contents to ensure that each provision is based on the law.

ii.Firming up responsibilities, preventing and controlling risks

Refine the requirements of the management standard, clear medical device network sales operators and platform operators should bear the social responsibility and obligations, prompting them to take the initiative to strengthen the quality risk prevention and control, and make every effort to protect the quality and safety of medical device products sold on the network.

iii. Summarizing experience and continuously optimize

In terms of content, the “Specification” is closely aligned with the newly revised “Good Supply Practice for Medical Devices”, and at the same time actively incorporates the useful practices and experiences of local regulatory authorities in the supervision and management of online sales of medical devices, and puts forward practical quality management requirements for online sales.

iv. Listening and energizing

Collecting extensively the problems encountered by all parties in the industry in the quality management of online sales of medical devices, actively understand the needs and expectations of enterprises, innovate regulatory concepts and methods, and implement the reform ideas of “delegating power, improving regulation, and upgrading services”. On the premise of safeguarding quality and safety, it responds to the demands of the industry, solves the difficulties of the industry, and creates conditions for the release of market innovation and vitality. The “Code” consists of four chapters and fifty articles, covering general provisions, quality management of online sales operators, quality management of e-commerce platform operators, and supplementary provisions. The core requirement is that online sales operators and e-commerce platform operators shall, in accordance with these regulations, establish and improve a quality management system suitable for the online sales of medical devices and ensure its effective operation.

III . What is the relationship between the “Specification” and the “Quality Management Specification for Medical Device Operation”?

The “Quality Management Specifications for the Online Sale of Medical Devices” and the “Quality Management Specifications for the Operation of Medical Devices” can be regarded as “brother chapters”. They complement each other in content and are at the same legal level. As a special form of business under the general concept of medical device operation, the online sale of medical devices requires relevant enterprises to first meet the requirements of regulations, rules, and specifications such as the “Regulations on the Supervision and Administration of Medical Devices”, the “Measures for the Supervision and Administration of Medical Device Operations”, and the “Quality Management Specifications for the Operation of Medical Devices” when conducting online sales activities.

Article 46 of the Regulations on the Supervision and Administration of Medical Devices clearly stipulates that entities engaged in the online sales of medical devices shall be medical device registrants, filers, or medical device business enterprises. Based on this, in many quality management aspects of online sales operators, such as the responsibilities of the quality management department, personnel, quality management system documents, incoming inspection and purchase and sales records, etc., the “Specification” takes the “Quality Management Practice for Medical Device Operations” as the basis, combines the characteristics of online sales, and puts forward targeted quality management requirements.

Ⅳ. How to effectively enforce the responsibilities of online sales operators?

i. Building a Quality Management System

Guiding online sales operators to establish and improve a quality management system suitable for the online sales of medical devices, refine the responsibilities of the quality management organization, enrich the content of personnel training, improve the formulation of system documents, and clarify the requirements for system self – inspection, etc.

ii. Standardizing sales quality management

Guiding online sales operators to display enterprise qualification information and product information in accordance with the law, improve online sales records and related credential information, and take effective measures to ensure the quality and safety of product transportation.

iii. Strengthening risk management

Medical device online sales operators are required to take risk control measures such as suspending product information display and sales in accordance with the law once they discover quality problems or safety hazards in their products.

Ⅴ. What are the requirements for the publicity of business entity information?

According to Article 15 of the E-commerce Law of the People’s Republic of China, e-commerce operators shall continuously publicize the business license information and administrative license information related to their business operations in a prominent position on their homepages. The “Specifications” implement the system of medical device registrants and filers, and put forward requirements for the publicity of enterprise entity information for different situations:

（i） Business enterprises that have obtained a medical device business license or completed the filing process are required to publicly display the medical device business license or the business filing certificate for Class II medical devices.

（ii） Medical device registrants who have obtained production licenses shall publicize their medical device production licenses.

（iii） Medical device registrants who entrust other enterprises to manufacture medical devices and conduct online sales are required to display the medical device registration certificates.

Medical device registrants who entrust other enterprises to manufacture medical devices and conduct online sales are required to display the medical device registration certificates.

Ⅵ. What are the special requirements for the sales of specially fitted medical devices?

Medical devices such as corneal contact lens and hearing aids need to go through fitting, adjustment or trial wearing before use to ensure that the products meet the specific needs of users and reduce the risk of use.Article 17 of the E-commerce Law of the People’s Republic of China stipulates that e-commerce operators shall comprehensively, truthfully, accurately and promptly disclose information on goods or services to protect consumers’ right to know and right to choose.

In view of the characteristics of these special products, the “Specification” requires that for online sales of medical devices with special fitting requirements such as corneal contact lenses and hearing aids, online sales operators should continuously display warning information such as “The fitting of this product should be carried out by optometry professionals” and “Before fitting a hearing aid, professional examinations and hearing tests should be carried out, and it should be used under the adjustment, trial listening, trial wearing and guidance of a hearing aid fitter” at a prominent position on the product page.

Ⅶ. How to refine the responsibilities of e-commerce platform operators?

i. Clarifying the responsibility for quality and safety management

E-commerce platform operators shall conduct real-name registration of online sales operators who access the network, review their medical device-related licenses, filings, etc., as well as the registration and filing of medical devices sold online, and adopt effective measures to manage the business operations of medical device operators within the platform.

ii. Improving the quality management system

Clarifying the responsibilities of the quality management institutions and personnel of e-commerce platform operators, refine the functions of the online trading system, improve the system documents covering the whole process of medical device online trading services, guide e-commerce platform operators to conduct quality management system audits, corrections and preventions, and ensure the effective operation and continuous improvement of the quality management system.

iii. Protecting the legitimate rights and interests of consumers

It is specified that e-commerce platform operators shall establish a complaint and reporting management system, disclose information such as complaint and reporting methods, urge the online sales operators within the platform to find out the causes of the quality and safety issues of the complained medical devices, take effective measures to handle and feedback in a timely manner, and keep relevant records. When necessary, e-commerce platform operators may take the initiative to investigate and handle complaints regarding the quality and safety issues of relevant medical devices.

Ⅷ. What are the special requirements for the staffing and organizational setup of e-commerce platform operators?

In terms of staffing, the “Specification” adheres to the principle of “putting people first” and focuses on the key minority. It clarifies that the legal representative or the principal person in charge of the e-commerce platform operator shall be fully responsible for the quality and safety of the online sales of medical devices; the person in charge of quality and safety management shall be responsible for the quality and safety management of the online sales of medical devices, assume corresponding responsibilities, and have the power to make decisions on the quality and safety management of medical devices within the enterprise.At the same time, legal representatives, principal responsible persons, and quality and safety management personnel of e-commerce platform operators are required to be familiar with the requirements of laws, regulations, rules, standards, etc., and shall not be in a situation where their practice is prohibited by relevant laws and regulations.

In terms of institutional setup, the “Specification” requires e-commerce platform operators to establish a medical device quality and safety management institution that is commensurate with the scale of medical device online trading services and the risk level of medical devices, and clarify the responsibilities of the institution. For those who have not established a quality and safety management institution, dedicated medical device quality and safety management personnel should be designated to perform the duties of the quality and safety management institution.

Ⅸ. What should the platform do when it discovers a breach?

The “Specification” requires that e-commerce platform operators should establish a system for detecting and handling illegal and irregular behaviors in the online sales of medical devices within the platform.Once it is discovered that an online sales operator within the platform fails to display business entity qualification information as required, fails to display product information as required, etc., the online sales operator shall be required to rectify immediately, and its violations and rectification situations shall be recorded.

If an e-commerce platform operator discovers that an online sales operator on the platform may be engaged in serious illegal acts such as selling medical devices without permission or filing, selling unregistered or unfiled medical devices, selling medical devices beyond the scope of business or business methods permitted or filed, or selling medical devices that are announced by the drug regulatory department as not allowed to be sold or used, it shall immediately stop providing corresponding online trading services, stop displaying information related to medical devices, and report to the drug regulatory department at the municipal level divided into districts where the online sales operator is located.

Ⅹ. How can the platform strengthen quality and safety risk management?

The “Specification” has outlined the paths and key indicators for e-commerce platform operators to continuously strengthen the risk management of the quality and safety of medical devices:

i. Implementing the responsibilities of personnel in key positions

Specifying that the legal representative or the principal person in charge of the e-commerce platform shall conduct at least one work consultation and summary on the quality and safety risks of the online sales of medical devices on the platform every quarter, and strengthen the responsibilities of key personnel.

ii. Strengthening internal risk monitoring

Guiding e-commerce platform operators to strengthen the internal monitoring of medical device quality and safety risks by conducting purchaser complaint analysis, quality inspection, etc.

iii. Paying attention to external risk information

E-commerce platform operators are required to actively pay attention to and collect regulatory dynamic information such as medical device supervision and inspection, administrative penalties, supervision and sampling, and product recalls released on the websites of drug regulatory departments, and conduct self-examinations in a timely manner.

iv. Taking risk control measures in a timely manner

In the face of product quality and safety risks discovered during monitoring and self – inspection, e – commerce platform operators must promptly adopt risk control measures such as self – inspection and rectification, suspending the release of product information, suspending sales, ceasing to provide online trading services, and reporting to the regulatory authorities, so as to comprehensively strengthen the risk management of medical device quality and safety.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source： Medical Enterprise Learning Network
Translated & edited：Bradyknown