On April 28, the National Medical Products Administration (NMPA) issued the Guidelines for Quality Management of Online Sales of Medical Devices (hereinafter referred to as the "Guidelines"), which will come into effect on October 1, 2025.

 

The publish of the "Guidelines" is a significant measure to implement the provisions of the E-Commerce Law of the People's Republic of China and the Regulations on the Supervision and Administration of Medical Devices, aim at guiding and regulating the quality management practices of medical device online sales operators and e-commerce platform operators, thereby ensuring the quality and safety of medical device online sales. Based on a thorough review of the basic requirements for online sales of medical devices, the "Guidelines" fully consider the actual quality management needs of all parties in the industry, further enhancing the standard of quality management for online sales of medical devices.

 

The "Guidelines" consist of four chapters and fifty articles, focusing on providing guidance on the management of medical device online sales and e-commerce platform operators:

 

1. Clarification of Basic Principles

Entities engaged in online sales of medical devices and those providing e-commerce platform services for medical device transactions should adhere to the principles of integrity and honesty, risk management, and ensure that the information of medical devices sold online is accurate, complete, and traceable. Effective measures should be taken to manage risks and ensure products quality associated with the online sale of medical devices.

 

2. Standardization of Online Sales Behavior

The "Guidelines" stipulate that enterprises engaged in online sales of medical devices must demostrate company and product information. For the company quality management system, the setup of quality management departments, personnel training, software and hardware equipment, system documentation, online sales records, and transportation management are all required.

 

3. Strengthening E-commerce Platform Management

The "Guidelines" guide e-commerce platform operators to implement effective quality control measures throughout the entire process of providing online transaction services for medical devices. Including establishment of systems, defining responsibilities, setting up institutions and personnel, managing documents and data, managing online operators, managing quality and safety risks, and conducting system audits and continuous improvement, to comprehensively ensure the quality, safety, and traceability of medical devices sold online.

 

This "Guidelines" is an important step in regulating and enhancing the quality management of medical device online sales, ensuring the safety and effectiveness of public use of medical devices, and promoting the development of the medical device industry. In the near future, the NMPA will organize training sessions and policy interpretation on the "Guidelines" to ensure proper implementation and compliance. This will effectively regulate the online sales behavior of medical devices, improve the quality management level of online sales of medical devices, and enhance the public awareness when purchasing medical devices online.

 

Reference

Issuance of the Guidelines for Quality Management of Online Sales of Medical Devices