关键词: font-size:medium, ">医疗器械；体外诊断试剂；延续注册

Abstract: Renewal registration is a crucial part of medical device registration. With the release and implementation of the new versions of the “Regulations on Supervision and Administration of Medical Devices”， “Administrative Measures for Medical Device Registration and Filing” and “ Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing”， the requirements for renewal registration have undergone significant changes. This article mainly introduces the material requirements for medical device/in vitro diagnostic reagent renewal registration（excluding work that needs to be continued post-marketing)， as well as the key points of the review process.

Key words: font-size:medium, ">Medical device； In-vitro diagnostic reagent； Renewal registration