为加强医疗器械检验机构能力建设,按照总局2016年度培训计划,4月24-29日,食品药品监管总局科技标准司在北京举办了医疗器械检验机构培训班。培训班由总局高研院承办。各省(区、市)医疗器械检验机构的相关负责人100余人参加了培训。
本次培训邀请国家认监委和总局法制司、器械注册司、器械监管司、器审中心、中检院等单位,直接参与相关法律法规起草工作或者长期从事监管、审评与检验工作的有关专家进行授课。培训班介绍了当前食品药品检验检测有关政策和形势,就医疗器械监督管理条例、医疗器械检验机构资质认定、医疗器械产品注册等相关法律法规和文件进行了权威解读,同时对医疗器械安全监管现状及监督抽检有关要求、检验机构实验室质量管理和能力验证等内容做了全面阐释。培训以专题授课为主,结合交流答疑、案例教学等形式,注重理论与实践相结合,提高了授课效果。培训班还就医疗器械检验机构运行与管理以及检验检测业务有关问题进行了专题座谈,听取大家的意见和建议。
参加培训的同志普遍认为,本次培训内容丰富、针对性强,对提升医疗器械检验机构检测能力、更好地服务于食品药品监管大局具有积极的推动作用。
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