Draft Order: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques for the Manufacture of Medical Devices
6 June 2007
Please note: This consultation closed on 13 July 2007.
Written submissions were invited on the following draft Order:
Background
This draft Order is based on the existing Australian Conformity Assessment Standards Order No. 1 but with references to the EN standards updated to reflect the latest international standards. The draft Conformity Assessment Standards Order (CASO) has been prepared in accordance with the proposed format for Orders to be made by the Australia New Zealand Therapeutic Products Authority (ANZTPA).
Under ANZTPA medical devices will need to demonstrate compliance with conformity assessment procedures relating to the manufacture of the medical device as outlined in the Medical Devices Rule. While compliance with CASOs will not be mandatory under the joint regulatory scheme administered by ANZTPA, the use of CASOs is encouraged because where these Orders exist, their use will lead to a presumption that the medical device complies with the relevant Conformity Assessment Procedures. If these Orders are not used, the manufacturer will need to demonstrate by other means that these requirements have been met.
URL: http://www.anztpa.org/consult/orders/drcaso-manuf.htm