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Standards orders and medical devices
What is a standard order
The Australian medical devices 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.
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.
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. Use of these standards is not mandatory, but if they are used, compliance with the Essential Principles or Conformity Assessment Procedures that they have been deemed to address is assumed.
Current standards orders are available at: Medical devices notices & standards orders.