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Core components of the medical devices regulatory system

Standards orders

Fact sheet: Medical devices & conformity assessment standards orders
<http://www.tga.gov.au/devices/fs-devstd.htm>

Medical device standards orders

Conformity assessment standards orders

  • Conformity Assessment Standards Order No. 1 of 2005
    <http://www.tga.gov.au/devices/caso1-2005.htm>

    Replacement of Conformity Assessment Standards Order No. 1: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques made on 20 February 2003
  • Conformity Assessment Standards Order No. 2
    <http://www.tga.gov.au/devices/caso2.htm>

    Conformity assessment standards for quality assurance techniques for animal tissues and their derivatives utilised in the manufacture of medical devices