In vitro diagnostic (IVD) medical devices are:
- a type of medical device
- used outside the human body.
We use the term ‘in vitro’ to mean testing of a human sample outside the body.
IVDs are used:
- to give information about a physiological or pathological state
- to monitor therapeutic measures (for example, medicine or biomarker levels in a patient)
- for screening for diseases, conditions, and ailments
- to assist health professionals in:
- making a clinical diagnosis
- making decisions for clinical management
- determining the safety and compatibility of therapeutic goods with a potential recipient.
IVDs are used by:
- health professionals:
- at a laboratory
- at point of care (near patient) testing
- the general public.
Example IVDs
- pregnancy test kit
- blood glucose meter and test strips
- COVID-19 test
- software for identifying abnormal cells in a sample
- laboratory developed test (in-house IVD) for genetic testing
Common forms of IVDs
- reagents
- calibrators
- control materials
- kits
- specimen receptacles
- software (including mobile apps)
- instruments
- apparatus.
More information
Supply a medical device
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PageGuidance on legally supplying medical devices in, and exporting them from, Australia.
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PageRegulatory responsibilities and expectations for manufacturers of medical devices, including in vitro diagnostics (IVDs).
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Reference materialThe guidelines provide information on the import, export and supply of medical devices within Australia.
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PageLinks to information on IVD medical devices, including HIV and nutrigenetic tests.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.