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Volume-based procurement is forcing industry upgrades, and sterile medical devices are ushering in a "materials revolution"
With the expansion of centralized volume procurement of medical consumables to include categories such as laparoscopic staplers and tissue forceps in the fourth quarter of 2024, the industry is undergoing a major reshuffle.
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Class II medical device review and approval speeds up, Zhejiang industrial cluster highlights innovation advantages
The National Medical Products Administration (NMPA) issued the 'Action Plan for Improving Efficiency and Quality of Medical Device Review and Approval' in September 2023, proposing a 'parallel review' for innovative Class II medical devices, reducing the average approval cycle from 180 days to 120 days. Zhejiang Provincial Drug Administration launched the 'Zhejiang-made Medical Devices' special campaign, establishing a 'pre-review guidance + priority testing' mechanism to help local enterprises obtain approval quickly.
Xinghe Medical releases intelligent sensing anastomosis device, minimally invasive surgery enters the era of precise quantification
At the 2024 China International Medical Equipment Fair (CMEF), Zhejiang Xinghe Medical Devices Co., Ltd. officially launched the "Zhiyingseries intelligent electric endoscopic stapler." This product innovatively combines fiber optic sensing technology with AI algorithms, allowing for real-time monitoring of parameters such as tissue thickness and blood vessel density, and automatically adjusting the stapling pressure to improve stitching precision to the 0.1mm level.
Zhejiang Xinghe Medical Device's 10,000-level cleanroom officially put into use, leading high-end manufacturing of sterile instruments with intelligent upgrades
In October 2024, Zhejiang Xinghe Medical Device Co., Ltd. announced that its new 10,000-level cleanroom, with a total investment exceeding 30 million yuan, has officially commenced operation. The cleanroom covers an area of 1200 square meters and adopts a laminar flow purification system. Its air cleanliness reaches Class 7 (10,000-level) as per ISO 14644-1, with certain operating areas achieving Class 5 (100-level).