摘要
第一类医疗器械备案是《医疗器械监督管理条例》(国务院令第650号)的一项全新制度设计,本文通过依托相关领域公认的基础理论和借鉴同类成熟可行的制度实践经验,对第一类医疗器械备案内涵和实质进行了研究,有助于读者对于第一类医疗器械备案的理解。
In the Regulation on the Supervision and Administration of Medical Devices （State Council Decree No.650）, there has a new system design, for class I medical device, the filing instead of the registration, according to the basic theory of relevant industry, use some mature experience of relevant system practice, this paper study the connotation and essence of class I medical device filing, help the reader to comprehend the filing.
出处
《中国医疗器械信息》
2014年第11期12-16,31,共6页
China Medical Device Information
