CAJ | 학술논문

内容:目前上市的部分医疗器械产品在其上市的注册证书中载明了商品名,但在实际医疗器械商品名管理过程中,特别是从医疗器械产品注册角度看,与药品商品名管理相比,还存在命名原则不明确、使用商品名产品过多等问题.本文通过调研了解国外监管要求,结合国内药品和其他产品商品名管理要求,对我国有关医疗器械商品名管理要求进行利、弊分析,并提出了有益的建议,为进一步规范医疗器械商品名管理提供了参考.
내용:목전상시적부분의료기계산품재기상시적주책증서중재명료상품명,단재실제의료기계상품명관리과정중,특별시종의료기계산품주책각도간,여약품상품명관리상비,환존재명명원칙불명학、사용상품명산품과다등문제.본문통과조연료해국외감관요구,결합국내약품화기타산품상품명관리요구,대아국유관의료기계상품명관리요구진행리、폐분석,병제출료유익적건의,위진일보규범의료기계상품명관리제공료삼고.
Some registration certifications of medical device specify the trade name, but ,in actual administration work, there has some problems, such as, lack of the code of medical device Nomenclature, too much medical device use the trade name. This paper investigate the administration of medical device trade name rule in foreign countries, integrate the drug and other prouducts trade name management legislation in china, Analysis of the pros and cons of regulatory requirements of medical device trade name and provide proposal and reference for medical device trade name administration.