广东省医疗器械产业现状及产品质量抽查检验情况

Analysis of Current Situation of Medical Device Industry and Sampling Inspection for Product Quality in Guangdong Province

随着人们健康意识的提升,社会各界对医疗器械的需求显著提高。作为直接影响人民群众健康安全的特殊商品,医疗器械是疾病预防、诊断、治疗、康复的重要支撑。作为医疗器械全生命周期监督管理的一环,抽查检验可直观反映市场现状及监管资源综合运用的情况。该研究主要介绍广东省医疗器械产业市场基本情况及广东省药品监督管理局近4年组织开展的抽查检验工作情况,并对发现的问题进行探讨,为各级药品监督管理部门有针对性的加强监督管理工作提供参考。

With the improvement of people's health awareness,the demand for medical devices from all sectors of society has also significantly increased.Mdical equipment,as a special commodity that directly affects the health and safety of the people,is an important support for disease prevention,diagnosis,treatment,and rehabilitation.Sampling inspection,as a part of the full lifecycle management of medical devices,can intuitively reflect the current market situation and the comprehensive utilization of regulatory resources.In this study,with the main introduction of the basic situation of the medical device industry market in Guangdong Province and the sampling inspection work organized by the Guangdong Provincial Drug Administration in the past four years,the discovered problems were discussed to provide reference for drug supervision and management departments at all levels to strengthen supervision and management.