中美临检类医疗器械产品监管比较研究

The Comparison Study of American and Chinese Regulatory System of Clinical Laboratory Medical Device

本研究通过对美国与我国临检类医疗器械产品的定义、分类、管理类别、市场准入模式、审批流程、技术审查要点等方面的对比分析和研究,结合我国临检类医疗器械产品的生产及管理现状的分析,得出结论我国在医疗器械法规体系、监管模式以及行政资本的有效利用上与美国还存在很大差距,指出要进一步完善我国临检类医疗器械的监督管理,需要使监督管理方式与临检类医疗器械的自身特点保持内在的一致,并且提出了建立动态化管理、闭环式管理、层次化管理、一体化管理体系,建立政府告知、企业承诺、符合性评估的企业许可审批制度等监管方式。本研究以中美两国临检类医疗器械产品的监管法规和技术审查指南文件为依据,对比了近两年来两国对临检类医疗器械产品的监管数据和技术审查方面的差异,从一类医疗器械产品的角度比较出了美国监管体系的合理性、充分性和有效性,为国内医疗器械监管体系的建设和完善以及行政资本的更有效利用提出了建设性意见。

The paper introduces the definition, classification, premarket admission and other administering specialities about clinical laboratory medical devices in the U.S.A and China. And by analyzing manufacture and administration of clinical laboratory medical devices in our country, it is pointed out the gap in regulatory system, administrative modality, the effective using of administration capital between China and the U.S.A and that a suitable administering model in accordance with the characteristics of clinical laboratory medical devices should be adopted to perfect the administration. The paper explicates the establishment of administrative modalities for medical device manufacture, raises up the idea of dynamic management, loop management, tiers management and integration management. The paper also present a variety of administrative modalities on qualification based manufacture license, i.e. government notice, manufacturer commitment, compliance evaluation. On the basis of analyzing the difference in administering data and technology evaluation by regulatory and guidance documents, the paper brings forth the rationality, satisfaction, availability of the American regulatory system and the constructive advice on administration is proposed in regulating medical devices.