title: [Clinical trial requests of indigenous diagnostic imaging ultrasound devices in first-time registration application].
abstract: This article introduces the clinical requests of indigenous diagnostic imaging ultrasound devices in first-time registration application and the clinical trial requests in Technical Review Guidance of Ultrasound Imaging Diagnostic Devices (category III) Registration and puts forward some questions of the guidance's implementation. It is hoped to help concerned people.
authors: Center for Medical Device Evaluation, SFDA, Beijing 100044. guozj@cmde.org.cn
authors: Zhaojun
authors: Z
authors: Guo
authors: Guofang
authors: G
authors: Cao
authors: Kan
authors: K
authors: Tao
mesh_terms: D002681:China; D002986:Clinical Trials as Topic / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D017408:Guidelines as Topic; D014463:Ultrasonography / Q000295:instrumentation*