Australia New Zealand
Therapeutic Products
Authority

Information last updated: 4 April 2007
URL: http://www.anztpa.org/consult/
   orders/drmdso-clinev.htm

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Draft Order: Medical Device Standards for Clinical Evidence

4 April 2007

Please note: This consultation closed on 4 May 2007.

Written submissions are invited on the following draft Order:

Medical Device Standards for Clinical Evidence (pdf,19kb)

Background

This draft Order is based on ISO and EN standards and on the existing Australian Medical Device Standards Order No. 1. The draft Medical Device Standards Order (MDSO) has been prepared in accordance with the proposed format for Orders to be made by the Australia New Zealand Therapeutic Products Authority (ANZTPA). This draft Order has been updated to reference the latest versions of the relevant international standards.

Under ANZTPA medical devices will need to comply with a set of 'Essential Principles' as outlined in the Medical Devices Rule. While compliance with MDSOs will not be mandatory under the joint regulatory scheme administered by ANZTPA, the use of MDSOs is encouraged because where these Orders exist, their use will lead to a presumption that the medical device complies with the relevant Essential Principles. If these Orders are not used, the manufacturer will need to demonstrate by other means that their product meets the Essential Principles.

URL: http://www.anztpa.org/consult/orders/drmdso-clinev.htm