Core Viewpoint - The National Medical Products Administration (NMPA) has established the "Priority Approval Directory for High-end Medical Devices (2025 Edition)" to expedite the registration process for certain medical devices [1] Group 1: Approval Process - The NMPA will implement priority approval for medical device registration applications listed in the directory according to Article 73, Section 3 of the "Regulations on the Registration and Filing of Medical Devices" [1] - The Medical Device Technical Review Center of the NMPA will review the registration application materials for products in the directory, and if approved for priority, the results will be publicly announced before entering the priority approval process [1] - If an application is not approved for priority, the NMPA will inform the applicant of the reasons and process it according to standard procedures [1] Group 2: Implementation and Future Adjustments - The directory will take effect immediately upon publication, and the NMPA will make adjustments as necessary in the future [1]
国家药监局发布《优先审批高端医疗器械目录（2025版）》
Di Yi Cai Jing·2025-12-26 08:22