On March 18, 2025, the National Medical Products Administration (NMPA) issued Announcement No. 30 of 2025, titled “Announcement on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices by Enterprises in China.” This announcement aims to refine the regulatory framework established by the 2020 Announcement No. 104, promoting the domestic manufacturing of imported medical devices and fostering high-quality development within the industry.
China’s NMPA Announces Rules for Domestic Production of Imported Devices
Expanded Scope of Application
The NMPA’s Announcement No. 30 of 2025 broadens the eligibility criteria for domestic production of imported medical devices. Previously, only8 foreign-invested enterprises (FIEs) directly established by the original registrant were eligible. The updated policy now includes enterprises that share the same actual controller as the original registrant. This change allows more entities to qualify for domestic manufacturing, potentially increasing local production opportunities for international medical device companies.
Refined Registration Requirements
To enhance regulatory oversight, the announcement introduces specific documentation requirements:
- Proof of Common Actual Control: Applicants must provide documentation demonstrating the relationship between the registrant and the applicant, such as descriptions of equity relationships and recent business reports containing information about the actual controller. These documents must be submitted to the relevant authorities and kept on file for verification.
- Authorization from the Registrant: The applicant is required to submit a notarized authorization letter from the original registrant, explicitly permitting the use of the registrant’s original application materials for local registration and production in China. This measure ensures proper authorization and protection of intellectual property.
Quality Management System (QMS) Verification
To maintain product quality and safety, the announcement outlines stringent QMS verification requirements:
- Commitment to Consistency: Applicants must commit that primary materials and production processes will remain unchanged during domestic manufacturing. A self-assessment report demonstrating compliance with China’s Good Manufacturing Practice (GMP) for Medical Devices is required, along with a comparative analysis of domestic and international quality management systems.
- Regulatory Authority Review: Authorities will conduct comprehensive reviews of the applicant’s QMS, focusing on the equivalence between domestic and imported systems. Any discrepancies must be thoroughly explained, with assurances that these differences will not lead to changes in the registered matters. A detailed risk analysis identifying key risk points and control measures is also required to ensure product safety, efficacy, and quality.
Support for Innovative Medical Devices
The NMPA emphasizes encouraging innovation within the domestic medical device sector. Imported innovative medical devices that meet specified requirements and are produced domestically will receive priority in registration and production permits. This initiative aligns with China’s broader goals of fostering innovation and enhancing the competitiveness of its medical device industry.
Implications for Stakeholders
This announcement reflects China’s commitment to regulatory modernization and alignment with global best practices. For medical device manufacturers, the key takeaways include:
- Expanded Opportunities: The broadened eligibility criteria allow more foreign-invested enterprises to engage in domestic production, leveraging existing registrations to expand their footprint in China.
- Streamlined Processes: The use of existing registration data and the emphasis on QMS consistency aim to simplify the transition to domestic manufacturing without compromising product quality or regulatory compliance.
- Innovation Encouragement: The prioritization of innovative medical devices underscores China’s dedication to fostering cutting-edge advancements within its domestic market.
Stakeholders are encouraged to familiarize themselves with the updated requirements and assess how these changes can facilitate their operations and strategic objectives within China’s evolving regulatory landscape.
Conclusion
The NMPA’s Announcement No. 30 of 2025 streamlines the domestic production of imported medical devices, expanding eligibility and refining regulatory requirements. These changes create new opportunities for foreign-invested enterprises while ensuring product quality and compliance. Manufacturers should stay informed, align with local GMP standards, and engage with regulators to navigate this evolving landscape effectively.
