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Guidance on Medical Device Standards Order (Standards for Risk Management) 2008
Medical Device Standards Order (Standards for Risk Management) 2008 specifies relevant medical device standards for the risk analysis and risk management methods concerning medical devices.
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.
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).