China Introduces New Policy to Boost Domestic Production of Imported Medical Devices
The National Medical Products Administration (NMPA) of China has announced updated measures to further optimize the domestic production of imported medical devices on March 18, 2025. The adjustments, published under the 2025 Announcement No. 30, aim to deepen medical device regulatory reforms and foster high-quality development in the industry. The revisions build on the previous framework established by 2020 Announcement No. 104, simplifying procedures and clarifying requirements for foreign-invested enterprises producing medical devices domestically.
Under the updated policy, foreign-invested companies eligible for domestic production include entities established by the original registrants of imported medical devices or enterprises under the same actual controller as the registrant. This applies to Class II and Class III medical devices with existing import registration certificates. The term "actual controller" follows the definition outlined in China’s Company Law, referring to individuals or entities that can exert control over a company through investments, agreements, or other arrangements.
The NMPA outlines that registrants can utilize original registration materials for product summaries, non-clinical data, and clinical evaluation data when applying for domestic production. However, compliance with China’s mandatory standards must be demonstrated through updated product technical requirements and inspection reports. Applicants under the same actual controller as the registrant must also provide documentation, including equity structure explanations and verified annual reports, to prove their relationship.
Additionally, the updated requirements emphasize quality system inspections. Registrants must submit self-assessments on compliance with China’s Good Manufacturing Practices for Medical Devices and provide comparisons between domestic and international quality management systems. Any differences in systems must be explained, and corresponding risk analyses and mitigation measures are required.
Priority processing is promised for innovative imported medical devices transitioning to domestic production, ensuring quicker approvals for related registration and licensing procedures. Chinese enterprises investing in overseas registrants can also apply to locally produce Class II and Class III devices within the updated framework. All follow-up changes and renewals to registration certificates will adhere to existing medical device registration and filing regulations.
This announcement reflects China’s continued efforts to create a more open regulatory environment and encourage the localization of advanced medical technologies. By streamlining regulatory processes and prioritizing innovative medical devices, China aims to solidify its position as a leading player in the global medical device industry.