关于新医疗器械注册申报资料重大变化研究比对

摘要

新的《医疗器械注册管理办法》（食品药品监督管理总局令第4号）已于2014年7月30日发布，并于2014年10月1日起实施。配套的《医疗器械注册申报资料要求和批准证明文件格式》也在9月5日以公告形式对外公布。为了更好地理解有关要求，本文对新旧注册申报资料之间部分重大变化进行了梳理和研究比对，以期对于医疗器械注册申报资料准备提供指导和帮助。%New provision on medical device registration had been issued and published by CFDA on 30th july,2014. Folowing, the new submission documents for medical device registration and format of certiifcation had been notiifed on 5th September. This paper investigate some important changes between the new normative ifles and the old requirements, In order to give a Guidance on comprehending the new requirements on medical device submission.