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根据国家医疗管理局5号令的规定,《医疗器械管理暂行办法》已从9月开始进入实施阶段。这是医疗器械行业的一件大事。这个办法是国家医疗管理局按照国务院批准确定的“三定”方案,在本部门的权限范围内发布的一项行政法规。是国家医疗器械行政管理机关及其工作人员实施医疗器械行政管理的法律依据,也是一切机关、团体、单位及个人在从事医疗器械开发、生产、经营时都必须遵守的行为规则。在我国,由于医疗器械行政管理基础比较薄弱,行政法规不完善,加上医疗器械产品
According to the provisions of the State Medical Administration’s Order No. 5, the “Interim Measures for the Administration of Medical Devices” has entered the implementation phase since September. This is a major event in the medical device industry. This method is an administrative regulation that is issued by the National Medical Administration in accordance with the “three-determined” plan approved and approved by the State Council. It is the legal basis for the implementation of the medical device administrative management by the national medical device administrative authorities and their staff. It is also a code of conduct that all organs, groups, units and individuals must follow in the development, production, and operation of medical devices. In China, due to the weak foundation of administrative management of medical devices, the imperfect administrative regulations and medical device products