YY/T 0595-2020
Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2003 (English Version)

Standard No.
YY/T 0595-2020
Language
Chinese, Available in English version
Release Date
2020
Published By
国家药监局
Latest
YY/T 0595-2020
Replace
YY/T 0595-2006
Scope
This standard provides guidance for the application of the medical device quality management system requirements contained in the YY/T 0287 standard. This standard does not add or change the requirements of YY/T 0287. This standard does not contain requirements for regulatory agency inspections or certification body assessment activities. This guide can be used to better understand the requirements of YY/T 0287 and to clarify some of the various available methods and approaches that can meet the requirements of YY/T 0287.

YY/T 0595-2020 history

  • 2020 YY/T 0595-2020 Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2003
  • 2006 YY/T 0595-2006 Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2003
Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2003



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