Regulatory Background
To implement the Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), and in accordance with the Measures for the Administration of Medical Device Registration and Record-filing (SAMR Order No. 47) and the Announcement of the NMPA on Measures to Optimize Life-Cycle Supervision and Support the Innovative Development of High-End Medical Devices (No. 63 of 2025), the NMPA has formulated the Catalog of High-End Medical Devices for Priority Approval (2025 Edition) (hereinafter referred to as the "Catalog"). The Catalog is hereby published, and relevant matters are announced as follows:
The NMPA shall implement priority approval for medical device registration applications listed in the Catalog, in accordance with Item (3) of Article 73 of the Measures for the Administration of Medical Device Registration and Record-filing.
Review and Evaluation Process
The Center for Medical Device Evaluation (CMDE) of the NMPA shall review application materials for products in the Catalog according to established procedures. If priority approval is proposed after review, the application will enter the priority approval process following a public notice period with no objections. If priority approval is denied, the applicant will be notified of the reasons, and the application will be processed under routine procedures.
Effective Date and Future Adjustments
This Catalog shall be effective as of the date of publication. The NMPA will make adjustments to the Catalog in the future as necessary.
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For companies developing innovative or high-end medical devices, understanding eligibility criteria and procedural expectations under China's priority approval pathway is critical. We support clients in assessing product eligibility, preparing registration strategies, and navigating interactions with the NMPA and CMDE.
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