China’s New Medical Device Management Law – Latest Updated Draft Released

China's new Medical Device Management Law was released for comments in August 2024 and in March 2025 the draft was issued again. Although this indicates a continued willingess to keep the momentum for introduction of the new law - which will raise regulation of medical devices to the law level same as drugs - various sources have indicated that implementation is not likely until 2026 at this time. The law, which replaces Decree No. 739 and continues the full life-cycle regulation of medical devices, emphasizes innovation as well as alignment with international standards. This article is a recap of the law changes and latest draft following requests for close updates from our clients.

Medical Device Regulation Reform: The Medical Device Management Law

Background and Significance of the "Medical Device Management Law"

China's medical device market has grown to be the world's second-largest, and the existing regulatory framework can no longer meet the current industrial demands. The introduction of this law is seen as a crucial step for China to integrate into the global medical regulatory system.

The "Medical Device Management Law" will replace the current Decree No. 739. The draft of this law (for public consultation) was released on August 28, 2024, and it will be the first to comprehensively regulate the development, production, operation, use, standards, classification, vigilance, and recall of medical devices in China.

Main Content of the "Medical Device Management Law" (Draft for Public Consultation)

Domestic Responsible Agent System: The new law introduces the concept of a "Domestic Responsible Agent (DRA)," requiring medical device registrants or filers to designate a DRA responsible for regulatory compliance in the Chinese market. This ensures the traceability and effectiveness of regulation. DRA will replace the previous "Legal Agent." DRAs must hold a production license or a Class III sales license to qualify. Their responsibilities will be enhanced, including recording every import and sale in China, with these records classified according to their record-keeping practices. The law also calls for the establishment of a coordinated medical device vigilance system, requiring manufacturers to pay more attention to post-market adverse event monitoring.
Full Life-Cycle Regulation: The new law comprehensively regulates the entire life cycle of medical devices, including product registration and filing, production, operation, use, adverse event monitoring, and recall.
Innovation Support and International Cooperation: The new law encourages innovation in medical device development and supports collaboration between enterprises, universities, research institutes, and medical institutions. It also actively participates in international standardization activities to promote the alignment of Chinese standards with international ones.
Enhanced Regulation and Penalties: The new law increases penalties for violations, setting clear legal responsibilities and punitive measures for failure to register, file, or produce medical devices that do not meet standards.

Impact on the Industry

Improved Industry Quality: The new law will encourage enterprises to focus more on product quality and safety, driving up the industry's overall quality.
Promotion of Industrial Innovation: By encouraging innovation and international cooperation, the new law offers policy support for technological innovation and industrial upgrading in the medical device industry.
Standardized Market Order: Strict regulation and penalties will effectively combat counterfeit and substandard products, creating a fairer competitive environment for law-abiding enterprises.
Enhanced International Cooperation: The implementation of the new law will facilitate Chinese medical device enterprises' connection with international markets, providing opportunities for their global development.

Impact on Overseas Manufacturers and Response Strategies

Regulatory Alignment and Compliance: Overseas manufacturers need to ensure their products meet China's latest medical device regulatory requirements, including registration, filing, production, and quality control.

Market Access Benefits: The new law aims to simplify the registration process for imported medical devices, allowing products that meet international standards to quickly enter the market through "equivalence assessment," significantly shortening the time to market.

Quality Management System: It is recommended that overseas manufacturers establish a compliance system in advance, focusing on the implementation details of the "Medical Device Management Law," and build a quality control process that meets China's Good Manufacturing Practice (GMP) to better respond to regulatory requirements and market changes.

Further Information

To read the original announcement about the draft Medical Device Management Law released by the State Administration for Market Regulation (SAMR), please click here.

If you are a medical device manufacturer with questions about how the draft Medical Device Management Law or new compliance requirements could affect your product registration in the China market, please contact Cisema.