无托槽隐形矫治器安全有效性分析

Safety and Effectiveness Analysis of Bracketless Invisible Appliance

根据《医疗器械注册管理办法》(国家食品药品监督管理总局令第4号)及《中华人民共和国药典》(2015年版),基于现行有效的国家标准、行业标准的要求,结合技术审评的要求及生产企业的研发经验对无托槽隐形矫治器的原材料控制、生物相容性评价、技术要求及临床评价等安全有效性方面进行分析。

We analyse Bracketless Invisible Appliance, including material management, biocompatibility evaluation, technical requirements and clinical evaluation according to the new provisions of CFDA for medical device and People＇s Republic of China Pharmacopoeia 2015 edition, based on the current valid national standards, industry standards, the experience of manufacturers＇ production and research.