Core Viewpoint - The article highlights the recent initiatives by the National Medical Products Administration (NMPA) to support the innovation and development of high-end medical devices, emphasizing the importance of regulatory reforms and support mechanisms for the medical device industry [2][3]. Group 1: High-End Medical Device Innovation - On June 20, the NMPA held a meeting to discuss measures to support the innovation of high-end medical devices, approving the "Measures to Optimize Lifecycle Regulation to Support High-End Medical Device Innovation" [2]. - The meeting underscored the central government's focus on high-end medical device innovation, with the 20th National Congress emphasizing the need to improve mechanisms supporting innovative medical device development [3]. - The "Measures" include ten specific actions such as optimizing special approval processes, refining classification and naming principles, and enhancing post-market surveillance requirements, which are crucial for fostering innovation in the medical device sector [3]. Group 2: Clinical Trial Approval for Innovative Drugs - On June 16, the NMPA released a draft announcement to optimize the review and approval process for innovative drug clinical trials, aiming to enhance the efficiency of clinical research [4]. - The new process allows for the review and approval of eligible innovative drug clinical trial applications within 30 working days, supporting key national research projects and encouraging international collaboration in clinical trials [4].
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证券时报·2025-06-20 12:49