Federal Register of Legislation - Australian Government

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MDSO No. 2 Orders/Other as made
This Order relates to the medical device standard for risk management.
Administered by: Health
Registered 10 Apr 2007
Tabling HistoryDate
Tabled HR18-Mar-2003
Tabled Senate19-Mar-2003
Gazetted 05 Mar 2003
Date of repeal 29 May 2008
Repealed by Medical Device Standards Order (Standards for Risk Management) 2008
Table of contents.




Subject:  MEDICAL DEVICE STANDARDS ORDER NO. 2 – Risk Management


Section 41CB, Therapeutic Goods Act 1989




Medical Device Standards Order No. 2 – Risk Management (MDSO 2) is an Order made by the delegate of the Minister for Health and Ageing under section 41CB of the Therapeutic Goods Act 1989 (the Act).


This Order specifies relevant medical device standards for the risk analysis and risk management methods concerning medical devices.


MDSO 2 was signed by the delegate of the Minister on 20 February 2003 and notified in the Commonwealth Gazette No. GN 9 on 5 March 2003.  MDSO 2 commenced on the day it was gazetted.




The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety and efficacy of therapeutic goods that are used in Australia or exported from Australia.


Section 41CB of the Act provides the Minister, or the Minister’s delegate, with the power to determine medical device standards and to also determine that medical devices that comply with these standards are to be treated as complying with specified parts of the essential principles.


The essential principles set out the requirements relating to the safety and performance characteristics of medical devices that must be complied with before a device can be imported, supplied or exported. Compliance with applicable medical device standards is not required, but it is one way to establish compliance with the essential principles. If a manufacturer chooses to apply a medical device standard, and this is applied correctly, the device is presumed to comply with the parts of the essential principles set out in the Order (section 41BH of the Act).


This Order determines medical device standards, which set methods for risk analysis and risk management in order to demonstrate compliance of medical devices with the essential principles.





Compliance with the proposed medical device standards is voluntary and members of industry may choose alternative means to demonstrate compliance with the Essential Principles.  All stakeholders, including industry and Standards Australia have been consulted during the development of the proposed new regulatory system for medical devices.  There was overall support for the adoption of international standards.  The Office of Regulation Review assessed the proposal for voluntary standards and, as it is not prohibitive either in terms of costs or time delays, the proposal is considered to be non-regulatory and as such a Regulatory Impact Statement is not required.