China: New Quality Guidelines for Online Medical Devices Sales (w.e.f 1 October 2025)

With the exponential rise of e-commerce in healthcare, China is taking significant steps to safeguard patient and product integrity through the newly issued guidelines, set to take effect on 1 October 2025.

This regulation outlines comprehensive requirements for both online sellers and e-commerce platform operators engaging in the sale of medical devices via the internet in China. The move is aligned with broader legislative frameworks, including the E-Commerce Law of the PRC and various medical device regulatory measures.

Key Takeaways from the Regulation

1.  Quality Management Systems (QMS) Are Mandatory

All online medical device sellers and platforms must establish and maintain a robust QMS that ensures traceability, compliance, and risk control, adapting to the scale and risk level of their operations.

2.  Clear Qualification Requirements

Sellers must display relevant business licenses and medical device certificates on their homepages and product listings. Platforms are responsible for verifying and monitoring these qualifications.

3.  Enhanced Data and Risk Monitoring

Both sellers and platforms must utilize technologies such as big data, AI, and cloud computing to detect and manage quality and safety risks proactively.

4.  Responsibilities for E-Commerce Platforms

Platforms must conduct real-name registrations for vendors, verify medical device qualifications, and monitor ongoing sales practices. Failure to comply or correct violations may result in reporting to municipal drug regulators.

5.  Transparency and After-Sales Service

Sellers must provide accessible after-sales support, complaint channels, and relevant medical warnings (especially for products like contact lenses and hearing aids).

6.  Domestic Data Storage

All data related to sales, logistics, and customer service must be stored within China, with adequate backup and disaster recovery systems in place

Why This Matters

The online sales of medical devices introduce unique challenges, from ensuring authenticity to maintaining device efficacy through proper transport and storage. These regulations not only enhance patient safety but also level the playing field for compliant businesses.

International medical device companies aiming to enter or expand in the Chinese market must begin aligning their online operations with these standards. Early preparation will be key to maintaining trust and continuity in this fast-growing sector.

Future Vision

The implementation of this regulation marks a significant advancement in the oversight of China’s digital health ecosystem. As the global medical device market continues to evolve, China’s move reinforces the importance of regulatory readiness, digital integrity, and patient-centric operations.

Source: National Medical Products Administration (NMPA)