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重点：明确了分类界定工作的定位和服务性质，完善了申请途径和流程，细化了申请资料要求，并强化了分类实施监督。 影响：有助于提高分类界定工作的透明度和一致性，更好地服务于医疗器械创新和发展。 分类界定结果目录. 《国家药监局关于规范医疗器械产品分类界定工作的公告》（2024年第59号） 中（三）对于新研制的尚未列入《分类目录》的医疗器械分类界定申请，申请人在分类界定信息系统中提交至国家药品监督管理局医疗器械标准管理中心（以下简称器械标管中心）。 器械标管中心负责组织研究明确分类界定意见，通过分类界定信息系统将分类界定结果告知申请人，并及时按照程序调整《医疗器械分类目录》器械标管中心负责对管理类别存疑的进口及港、澳、台产品医疗器械分类界定申请和省级药品监督管理部门出具预分类界定意见的医疗器械分类界定申请组织研究，明确分类界定意见，并通过分类界定信息系统将分类界定结果告知申请人。. Com › 4498137472 › 285577459重磅！2024年第一次「医疗器械产品分类界定结果汇总」发布.

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