医疗器械审评与注册核查衔接现状探讨

Discussion on the Connection Between Medical Device Evaluation and Registration Verification

以中医熏蒸治疗设备为例,通过企业座谈、调研、省级审评查验中心的问卷调查,汇总研究医疗器械审评与注册核查相衔接的现状及问题,并提出解决建议,期望有利于提升审评人员能力,改革审评制度,促进医疗器械行业高质量发展。

Taking traditional Chinese medicine fumigation treatment equipment as an example,this paper summarizes the current situation and problems of the connection between medical device evaluation and registration verification through symposium,researching with enterprises and questionnaire survey of provincial evaluation and inspection centers,and puts forward some suggestions to improve the personal competence,reform the evaluation system,and promote the highquality development of medical device industry.