医疗器械职业化专业化检查员培训体系分析及建设研究

Analysis and Construction Research on the Training System for Professional Medical Device Inspectors

医疗器械职业化专业化检查员队伍能力的提升,事关医疗器械监管事业健康发展。目前,我国医疗器械检查员的培训体系已不能满足医疗器械行业蓬勃发展的要求。本文围绕我国职业化专业化医疗器械检查员培训体系展开研究,介绍了发达国家或地区医疗器械检查员制度及检查员培训经验,分析了我国医疗器械检查员制度的进展及培训存在的问题、岗位胜任能力,并在此基础上构建我国医疗器械检查员培训体系,以期为完善我国职业化专业化医疗器械检查员队伍建设提供参考借鉴。

The improvement of professional and specialized skills among medical device inspectors is crucial for the healthy development of medical device regulation.Currently,the training system for medical device inspectors in China can no longer meet the demands of the thriving medical device industry.This article focuses on the analysis and construction of a training system for professional and specialized medical device inspectors in China.It introduces the medical device inspector system and training experience from developed countries or regions,examines the progress and existing issues in China’s medical device inspector system,and analyzes the competencies required for the job.Based on these findings,a training system for medical device inspectors in China is proposed,aiming to provide reference for the improvement of the professionalization and specialization of medical device inspectors in China.