China National Standards

China Medical device quality GB Standards List


  •  China "Medical device quality" GB Standards List:
  • Standard  Code Standard Title Standard Class Order
    GB/Z 42217-2022 Medical devices for the validation of Medical device quality system software {译}
    医疗器械 用于医疗器械质量体系软件的确认
    China National Standards
    Medical device quality

    English PDF
    GB/T 42218-2022 Laboratory medicine - In vitro diagnostic medical devices - Manufacturer's confirmation of quality control procedures provided to users {译}
    检验医学 体外诊断医疗器械 制造商对提供给用户的质量控制程序的确认
    China National Standards
    Medical device quality

    English PDF
    GB/T 42061-2022 Medical device quality management system for regulatory requirements {译}
    医疗器械 质量管理体系 用于法规的要求
    China National Standards
    Medical device quality

    English PDF

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