摘要
体外诊断产品涉及疾病预防、诊断、治疗方案选择、疗效评价等,其质量水平直接影响诊断的正确性。在正确辨识体外诊断类产品的风险基础上,进行合理分类,对实现科学监管,节约监管资源,促进体外诊断产业的健康发展具有重要意义。该文通过对欧美体外诊断产品分类管理的体制分析,结合我国分类监管的现状及存在的问题,提出改革和完善我国体外诊断产品分类监管的意见和建议。
In vitro diagnostic products(IVD) involved in disease prevention, diagnosis, treatment options, efficacy evaluation, etc., the quality level directly affects the accuracy of diagnosis. Based on the correct identification of the risk of IVD, a reasonable classificationis of great significance to achieve scientific regulation, conservation of regulatory resources, promote the healthy development of the in vitro diagnostics industry. In this paper,opinions and suggestions on the reform and perfecting the regulatory classification of IVD in China is put forward through the analysis of the classification management system of IVD in Europe and the United States, combined with the status quo of China’s regulatory classification and existing problems.
出处
《中国医疗器械杂志》
2016年第4期271-274,共4页
Chinese Journal of Medical Instrumentation
关键词
体外诊断
医疗器械
分类
IVD
medical device
classification
