中国医疗器械杂志
中國醫療器械雜誌
중국의료기계잡지
CHINESE JOURNAL OF MEDICAL INSTRUMENTATION
2014年
1期
61-64
,共4页
医疗器械%临床试验%GCP
醫療器械%臨床試驗%GCP
의료기계%림상시험%GCP
medical device%clinical trial%GCP
《医疗器械临床试验规定》等一系列法规是目前我国进行医疗器械临床试验的主要法律依据。该文基于我国医疗器械临床研究的现状，对这些法规中若干热点问题加以解读和剖析，旨在探索完善我国医疗器械临床试验监管体系的途径，为医疗器械业内人士及医疗器械临床试验的研究者和管理者提供参考。
《醫療器械臨床試驗規定》等一繫列法規是目前我國進行醫療器械臨床試驗的主要法律依據。該文基于我國醫療器械臨床研究的現狀，對這些法規中若榦熱點問題加以解讀和剖析，旨在探索完善我國醫療器械臨床試驗鑑管體繫的途徑，為醫療器械業內人士及醫療器械臨床試驗的研究者和管理者提供參攷。
《의료기계림상시험규정》등일계렬법규시목전아국진행의료기계림상시험적주요법률의거。해문기우아국의료기계림상연구적현상，대저사법규중약간열점문제가이해독화부석，지재탐색완선아국의료기계림상시험감관체계적도경，위의료기계업내인사급의료기계림상시험적연구자화관리자제공삼고。
A series of laws and regulations are the essential legal requirement in the field of clinical trial of medical device currently in China, especial y the Provision for Clinical Trial of Medical Device. On the basis of current situation of medical device clinical trial, systemic analysis on the hot spot topics in the regulations was conducted to explore the way of improving the control system of clinical trial of medical device in China, which wil provide the reference for medical device industry and the investigators of the clinical trial of medical device.
