摘要新修订的《医疗器械注册管理办法》（食品药品监督管理总局令第4号）及配套的《关
于公布医疗器械注册申报资料要求和批准证明文件格式的公告》（食品药品监督管理总局令第
43号）引入了美国FDA 申报510k的思路，本文通过将《医疗器械注册申报资料要求及说明》和
美国FDA《传统和简化510k的格式指导原则》（Guidance for Industry and FDA Staff Format for
Traditional and Abbreviated 510ks）做对比，以骨科脊柱产品为例，浅析二者之间的异同点，以期
对医疗器械注册申报资料的准备工作提供指导和帮助。
Abstract：The newly revised Provisions for Medical Device Registration (CFDA No.4) and Requirements and
Instructions for Medical Device Registration Application (CFDA No.43) introduced the idea of premarket
notification 510k of US Food and Drug Administration (FDA). This study made a comparison between
the Requirements and Instructions for Medical Device Registration Application and the Guidance for
Industry with the Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510ks.
By using the orthopedic spinal products as examples, this paper analyzes the similarities and differences
between the two documents, in order to provide guidance and assistance for the medical device
registration dossiers preparation.
孔玮娜，程云章. 关于骨科脊柱产品申报美国上市前通告
和国内注册申报资料的要求对比研究[J]. 中国医疗设备, 2016, 31(2): 172-174.
KONG Wei-na,
CHENG Yun-zhang. A Comparative Study on the Premarket Notification in the United States and
the Requirements for Domestic Registration for Orthopedic Spinal Products. China Medical Devices, 2016, 31(2): 172-174.
