日本的医疗器械注册由日本厚生劳动省(Ministry of Health, Labour and Welfare,MHLW)和医疗器械审评机构(Pharmaceuticals and Medical Devices Agency,PMDA)负责管理和监管。以下是一般情况下日本PMDA医疗器械注册的流程:
在日本,医疗器械的注册由日本厚生劳动省(Ministry of Health, Labour and Welfare,MHLW)和医疗器械审评机构(Pharmaceuticals and Medical Devices Agency,PMDA)负责管理和监管。以下是关于日本医疗器械认证PMDA注册的一般步骤: