国家药品监督管理局近日就《人工智能辅助诊断医疗器械临床评价注册审查指导原则（征求意见稿）》公开征求意见，拟对AI形态学分析设备的性能验证、数据安全和临床评价提出系统化要求，为行业规范化发展提供政策参考。
The National Medical Products Administration recently released for public comment the draft 'Guiding Principles for Clinical Evaluation Registration Review of AI-Assisted Diagnostic Medical Devices,' outlining proposed systematic requirements for performance validation, data security, and clinical evaluation of AI morphology analysis devices.
此次征求意见稿聚焦人工智能辅助诊断类产品在临床评价环节的证据要求与审查路径，强调算法性能、数据质量与临床适用性之间的系统衔接，有助于进一步明确企业在注册申报中的关键评价维度。
对形态学智能检测企业而言，这意味着产品研发需更早嵌入合规与验证设计。珙辉生物将持续关注相关政策进展，对标审评要求，完善数据治理与临床评价能力，稳步推进 MA30V 等产品的合规与质量体系建设。
The draft focuses on evidence requirements and review pathways for AI-assisted diagnostic products in clinical evaluation, emphasizing the systematic alignment of algorithm performance, data quality, and clinical applicability to clarify key evaluation dimensions for registration.
For morphology AI companies, this means compliance and validation should be built into R&D earlier. Gonwing will continue monitoring policy developments, aligning with review expectations, strengthening data governance and clinical evaluation capabilities, and advancing compliance and quality systems for products such as MA30V.
