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Updated medical device & conformity assessment standards orders
This consultation opened on 21 December 2007 and closed on 15 February 2008.
The following letter was sent to key industry organisations in December 2007. All interested stakeholders were invited to comment on this proposal.
In preparation for the move to a joint regulatory scheme under the Australia New Zealand Joint Therapeutic Products Authority (ANZTPA) Australia's MDSOs and CASOs were redrafted in the ANZTPA format and sent out for stakeholder comment during April - June 2007.
As part of the redraft and consultation the following four standards orders were updated to reflect the latest international standards:
- CASO 1 Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques (pdf,37kb)
- MDSO 1 Medical Device Standards for Clinical Evidence (pdf,20kb)
- MDSO 2 Medical Device Standards for Risk Management (pdf,20kb)
- MDSO 3 Medical Device Standards for Medical Devices Required to be Sterile (pdf,39kb)
With the postponement of ANZTPA it has been agreed that the TGA should look to harness the large volume of useful work undertaken for the planning of ANZTPA. Updating the MDSOs and CASOs to reflect the latest international standards is one of these tasks.
The draft Orders attached, which reference internationally harmonised standards, are updated versions of existing Australian Orders. These updates reflect stakeholder comments during ANZTPA consultations. Your comments are sought on the proposal to register these revised Orders in the Federal Register of Legislative Instruments (FRLI).
It is proposed that the new Orders be registered on FRLI as soon as practicable after the consultation period and that they commence on the day after they are registered in FRLI.