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Guidance on Medical Device Standards Order (Standards for Clinical Evidence) 2008

16 June 2008

Medical Device Standards Order (Standards for Clinical Evidence) 2008 specifies medical device standards relevant to medical devices that require clinical evidence in order to demonstrate compliance with the essential principles.

This Order is for all medical devices for which clinical evidence is required to demonstrate compliance to the essential principles.

Item 1 of the Schedule to this Order provides a method for the generation of clinical evidence. Item 1 determines "how" to conduct clinical investigations that form part of the clinical data required to address one or more of the essential principles (ie. general requirements, methodology, documentation, clinical investigation plan, role of the sponsor, role of the clinical investigator, presentation of results, etc.). Item 1 does not specify the "type" of clinical data required to address the essential principles.

Items 2 and 3 of the Schedule to this Order determine the "type" of clinical data required for particular kinds of devices. Future amendments to this Order may include insertion of new items related to other particular kinds of devices.

The application of Item 1 does not remove the need to comply with the particular requirements set in the Therapeutic Goods (Medical Devices) Regulations 2002 with regard to clinical evidence. Clinical trials in Australia must be conducted in accordance with these requirements, which include the ethical standards set out in the National Health and Medical Research Council's National Statement on Ethical Conduct in Research Involving Humans, as in force at the time of the conduct of the trial.

Clinical trials conducted overseas must be in accordance with the principles of the Declaration of Helsinki.

Background

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).

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