Clinical trial requests of indigenous diagnostic imaging ultrasound devices in first-time registration application.
- Author:
Zhaojun GUO
1
;
Guofang CAO
;
Kan TAO
Author Information
1. Center for Medical Device Evaluation, SFDA, Beijing 100044. guozj@cmde.org.cn
- Publication Type:Journal Article
- MeSH:
China;
Clinical Trials as Topic;
standards;
Device Approval;
legislation & jurisprudence;
standards;
Guidelines as Topic;
Ultrasonography;
instrumentation
- From:Chinese Journal of Medical Instrumentation
2012;36(6):438-440
- CountryChina
- Language:Chinese
-
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.
