口腔骨缺损修复
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 海利生物控股子公司骨修复材料注册申请获受理
 Zhong Jin Zai Xian· 2025-09-02 06:02
 Core Viewpoint - Shanghai Haili Biological Technology Co., Ltd. announced that its subsidiary, Shaanxi Ruisheng Biotechnology Co., Ltd., has received a notice of acceptance from the National Medical Products Administration for the registration application of three types of medical devices, specifically "bone repair materials" [1]   Group 1: Product Details - The products are classified as Class III medical devices, suitable for filling and repairing maxillofacial bone defects and alveolar bone defects (or insufficient bone volume) [1] - The application includes structured products such as block and column types, which can better match the bone defect areas compared to the existing granular bone repair materials, effectively reducing bone powder displacement and improving surgical efficiency and osteogenic effects [1]   Group 2: Regulatory Process - The registration application is currently in the review and approval stage, with a statutory administrative approval period of 20 working days, which can be extended by an additional 10 working days under special circumstances [1]   Group 3: Market Implications - If the product is successfully approved for market launch, it will enrich Haili Biological's product line in the field of oral bone defect repair [1] - The company notes that the product is still in the acceptance stage, and its impact on future performance remains uncertain [1]