浅谈我国医疗器械监管新法规体系下医疗器械生产企业应对建议

摘要

自2014年新条例颁布以来,国家食品药品监督管理总局(CFDA)在原中国医疗器械监管法规基础上,开展了大规模医疗器械法规制修订工作,目前已逐步形成适应医疗器械行业发展的医疗器械监管新法规体系,对整个行业的健康发展将产生深远影响.本文从医疗器械生产企业的视角,研究医疗器械监管新法规体系的主要变化,就医疗器械生产企业如何适应新的监管法规体系要求提出相关建议.%Since the releasing of Order 650 in 2014, China Food and Drug Administration (CFDA) organized professionals to intensively formulate and revise regulations based on the original medical device supervision regulations system. Up to now, China medical device supervision new regulation system has been formed basically and has profound active implications on the whole medical device industry. The article analyzed the change of requirements of medical device supervision new regulation system from manufacture's point of view and tried to provide some simple suggestions of adapting them.