Standards orders
Fact sheet no. 24
October 2006
1. What is a standard order
The new legislation creates a system of non-mandatory medical device standards orders (MDSO) and conformity assessment standards orders (CASO) that can be used to demonstrate compliance with the Essential Principles or Conformity Assessment Procedures. These standards replace the system of mandatory TGO's that existed for therapeutic devices under the old regulatory system.
The new legislation creates the medical device standards and conformity assessment standards as "matters specified in the order published in the gazette". The "matters" include the list of selected international or Australian standards or monographs from the BP, EP or USP, but the order must also specify how the Conformity Assessment Procedures and the Essential Principles are demonstrated by the standard ie. which clauses demonstrate compliance with Essential Principles or the Conformity Assessment Procedures. Additional or alternative "matters" may also be specified in the order.
2. Compliance with a standard order is not mandatory
There are no mandatory standards under the new regulatory system instead medical devices must comply with a set of Essential Principles that define the basic principles for quality, safety and performance of the device. The legislation also sets out Conformity Assessment Procedures that the manufacturer must use to demonstrate that the Essential Principles have been met.
3. Why comply with a standard order
While there are no mandatory standards under the new regulatory system the use of standards referenced in an MDSO or CASO is encouraged because where these standards exist, their use is the best method to demonstrate compliance with the Australian requirements. , but if they are used, compliance with the Essential Principles or Conformity Assessment Procedures that they have been deemed to address is assumed.
Standards orders
- Medical Device Standards Order (Standards for Clinical Evidence) 2008
<http://www.tga.gov.au/legis/mdsoce2008.htm>
Medical device standards for clinical evidence - Medical Device Standards Order (Standards for Risk Management) 2008
<http://www.tga.gov.au/legis/mdsorm2008.htm>
Medical device standards for risk management - Medical Device Standards Order No. 3
<http://www.tga.gov.au/devices/mdso3.htm>
Medical device standards for medical devices required to be sterile - 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