The National Medical Products Administration (NMPA) has published an interpretation of Announcement No. 30, 2025, introducing adjustments to facilitate the domestic production of imported medical devices by enterprises in China. The new approach, effective from 18 March 2025, is intended to support localization, streamline application requirements, and encourage the transfer of innovative medical technologies into the Chinese manufacturing ecosystem.
Background
This announcement builds on Announcement No. 104 (2020) and follows the issuance of policy guidance by the State Council to support the localization of high-end imported medical devices. The updates respond to stakeholder feedback and aim to align China’s registration framework with principles of scientific, risk-based regulation.
Key Adjustments and Clarifications
1. Expanded Definition of Foreign-Invested Enterprises
Previously, eligibility for domestic production under Announcement No. 104 was limited to enterprises directly established by the registrant. Now, it includes:
- Entities established by the registrant, or
- Entities sharing the same actual controller as the registrant.
The actual controller must comply with China’s Company Law and may influence company actions via investment, agreements, or other arrangements.
2. Streamlined Registration Application Dossier Requirements
Applicants may now:
- Submit original registration dossiers from the imported product, including:
- Summary data
- Non-clinical data (except for the list of basic principles of safety and performance, product technical requirements, and test reports)
- Clinical evaluation data
- However, product technical requirements and test reports must confirm compliance with applicable mandatory Chinese standards.
In addition:
- A statement and documents proving the relationship between the applicant and original registrant (e.g., equity disclosure, Enterprise Annual Reports) must be included.
- A notarized Letter of Authorization from the original registrant is required, granting permission to use their registration dossiers for domestic application and production purposes.
3. Optimized Quality Management System (QMS) Verification
Authorities will:
- Focus on the equivalence of domestic vs. overseas QMS during registration.
- If systems differ, applicants must:
- Explain the differences
- Show they do not affect registered product items
- Provide risk analysis and control measures
- Ensure safety, effectiveness, and quality remain intact
4. Prioritization of Innovative Products
For innovative imported devices transitioning to domestic production, NMPA will:
- Prioritize registration and licensing procedures.
- Allow future change registrations and renewals to be handled independently from the original imported product registration.
This opens the door for faster market access and manufacturing autonomy for advanced technologies in China.
Published by NMPA on 11 June 2025
