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
- Medical Device Standards Order (Standards for Clinical Evidence) 2008
<http://www.tga.gov.au/legis/mdsoce2008.htm> - Medical Device Standards Order (Standards for Risk Management) 2008
<http://www.tga.gov.au/legis/mdsorm2008.htm> - Medical Device Standards Order No. 3 Medical Device Standards for Medical Devices Required to be Sterile
<http://www.tga.gov.au/devices/mdso3.htm>
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
