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最近,山东省医药局出台了《山东省医疗器械产品评审办法》(试行)。主要内容如下: 一、山东医疗器械产品评审由省医药局组织并主持,也可委托市地医药主管部门主持。 二、评审范围:经山东省医药局批准受理的二类医疗器械产品,主要指生物医学机理尚无定论或未有相似原理、相似机理及相似结构的产品在市场出售的产品;与山东省已批准上市的产品相比,结构、原理、主要性能指标或用途有明显差异的产
Recently, the Shandong Provincial Department of Medicine issued the “Measures for the Evaluation of Medical Devices in Shandong Province” (for trial implementation). The main contents are as follows: 1. The review of Shandong medical device products shall be organized and presided over by the Provincial Bureau of Medicine, and may also be entrusted by the municipal competent department of local medicine. Second, the scope of assessment: Approved by the Shandong Provincial Department of Medicine, the second category of medical device products, mainly refers to the biomedical mechanism has not been conclusive or similar principles, similar mechanisms and similar structures of products sold in the market; with Shandong Province Compared with products approved for listing, there are significant differences in the structure, principle, major performance indicators or applications.