我国医疗器械注册产品标准复核与预评价

摘要

This paper researched on course of registration and administrative licensing for medical device product specification, analyzed the existing demands of review and pre-evaluation, discussed about how to improve and manage pre-evaluation results for testing laboratory and manufacturer in China, based on “Provision of Medical Device Product Specification Standardization”, “Provision on Medical Device Registration” and relative documents of States Food & Drug Administration. It suggested that set up and maintain a professional team of review and approval staff, further strengthen standardization of medical device specification, arming at current situations of non-compatibility between documents and inconformity of performance in different provinces. It paid attention to control the quality of medical device to ensure the core of safety and effectiveness for using medical device.%　　该文结合《医疗器械标准管理办法》、《医疗器械注册管理办法》和国家食品药品监督管理局的相关管理文件，分析在医疗器械注册产品在注册和行政审批过程中实施标准复核、预评价的要求及其具体内容，探讨检测机构和生产者对于评价意见的处理办法。针对目前存在的文件要求不协调和各地执行不统一的现状，提出提高各级人员专业化程度和医疗器械标准化管理的建议，以达到提高医疗器械产品质量，确保产品质量可控并满足医疗器械安全、有效的核心目标。