医疗器械注册产品标准复核常见问题分析
의료기계주책산품표준복핵상견문제분석
Analysis of the Common Problems of Standards During Medical Devices Registration
  • 万方数据
    中国医疗器械杂志 중국의료기계잡지
    CHINESE JOURNAL OF MEDICAL INSTRUMENTATION
    2014年 2期 133-135 ,共3页

    颜敏%曹俐%吴明军

    안민%조리%오명군

    医疗器械%注册产品标准%问题分析 醫療器械%註冊產品標準%問題分析
    의료기계%주책산품표준%문제분석
    medical device%registration product standard%problem analysis
    根据医疗器械注册产品标准编写规范，结合标准复核的工作实践，对医疗器械注册产品标准复核过程中发现的常见问题进行了分析，并提出了相应的建议。旨在规范注册产品标准的编写，加速产品标准化进程，促进行业规范发展。
    근거의료기계주책산품표준편사규범，결합표준복핵적공작실천，대의료기계주책산품표준복핵과정중발현적상견문제진행료분석，병제출료상응적건의。지재규범주책산품표준적편사，가속산품표준화진정，촉진행업규범발전。
    According to the registered product standards specification of medical devices, combined with the standard reviewing work, the common problems of standards during medical devices registeration were analyzed and corresponding suggestions were proposed to standardize the standard of the registered product, accelerate the standardization and promote the industry standardized .
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