China’s National Medical Products Administration (NMPA) recently issued the Announcement on Further Adjusting and Optimizing the Production of Imported Medical Device Products in Enterprises in China (No. 30 [2025]), signaling an important regulatory shift for foreign medical device companies operating in the Chinese market. The policy, which took effect on March 18, 2025, builds upon previous regulations and aims to streamline the localization of imported medical devices, encourage innovation, and enhance regulatory efficiency.
This article provides an analytical overview of the policy’s background, core principles, and key regulatory changes while assessing its potential impact on multinational medical device manufacturers and domestic enterprises.
Background: Strengthening the Domestic Medical Device Industry
The latest announcement is a continuation of efforts to accelerate the localization of medical devices in China. In 2020, the NMPA issued Announcement No. 104, which simplified registration procedures and helped foreign manufacturers establish domestic production facilities. However, as China continues to emphasize domestic innovation and supply chain resilience, the new guidelines introduce further refinements to expand eligibility, clarify registration requirements, and streamline regulatory approvals.
This policy aligns with China’s broader regulatory reforms outlined in the Opinions on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices and Promoting the High-Quality Development of the Pharmaceutical Industry (2024). The document explicitly calls for optimized approval processes for transferring production of internationally approved medical devices to China, as well as stronger support for foreign investment in the country’s medical device sector.
Key Regulatory Changes and Adjustments
The updated policy refines previous regulations by introducing four major adjustments:
Expanded Eligibility for Domestic Production
- The term “foreign-invested enterprise” is redefined to include both subsidiaries of imported medical device registrants and enterprises with the same actual controller.
- The actual controller must meet the Company Law of the People’s Republic of China definition, ensuring compliance with ownership transparency and regulatory oversight.
- This change expands the range of companies eligible to establish production facilities in China, facilitating easier market entry for multinational corporations with domestic partnerships.
Streamlined Registration and Application Requirements
- Simplified Documentation: Applicants can now reuse existing technical documentation from their original imported medical device registration, reducing administrative burdens.
- Enhanced Transparency: Companies must provide proof of common ownership or control between the domestic and foreign entity.
- Authorization Letter Requirement: The domestic entity must obtain a notarized authorization letter from the foreign manufacturer explicitly allowing the use of registration materials in China.
These changes make the transition more efficient and transparent, allowing foreign companies to leverage their existing regulatory approvals for smoother entry into the domestic market.
Optimized Quality Management System (QMS) Verification
- The NMPA will assess equivalency between the domestic and foreign quality management systems.
- Companies must justify any differences between their imported and domestically produced versions, conducting risk assessments to ensure compliance with safety and efficacy standards.
- This approach ensures regulatory consistency while allowing for flexibility in manufacturing practices.
Prioritization of Innovative Medical Devices
- The new policy places special emphasis on innovation, granting priority review for the registration and licensing of innovative medical devices that transition from foreign to domestic production.
- This is particularly relevant for high-end medical technologies, including advanced imaging systems, AI-assisted diagnostics, and personalized medical devices.
By supporting technology transfer and domestic production, the policy encourages foreign companies to invest in R&D partnerships within China.
Implications for Foreign Medical Device Companies
Increased Market Access with Localized Manufacturing
Foreign medical device manufacturers seeking long-term expansion in China now have a clearer and more structured path to establish local production facilities. By setting up subsidiaries or partnerships, companies can:
- Reduce import dependency and supply chain risks.
- Access government incentives for local manufacturing and innovation.
- Improve pricing competitiveness by lowering production and distribution costs.
Regulatory Efficiency and Accelerated Market Entry
The ability to reuse existing foreign registration materials simplifies documentation requirements, shortens approval timelines, and eliminates redundancies. Companies that align their quality management systems with Chinese standards will likely benefit from faster approval processes.
Competitive Pressure for Domestic Manufacturers
While this policy facilitates foreign investment, it also introduces greater competition for domestic medical device manufacturers. Local firms will need to accelerate R&D efforts and improve quality standards to maintain their market share.
Conclusion: A Strategic Shift for China’s Medical Device Industry
The 2025 regulatory update represents a strategic move by China to further integrate foreign medical device innovation into its domestic healthcare ecosystem. By simplifying regulatory processes, promoting localized production, and prioritizing high-tech medical devices, the policy strengthens China’s position as a leading medical device market while maintaining regulatory rigor and patient safety.
For foreign medical device companies, this is an opportunity to establish a stronger foothold in China. For domestic players, it signals the need for faster innovation and higher quality standards to compete in an evolving market landscape.
As the healthcare sector continues to grow, companies that leverage these regulatory changes effectively will be well-positioned to thrive in the competitive Chinese medical device industry.