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Safety monitoring: medical devices
We make sure that therapeutic goods in Australia are safe. If there are any safety concerns, we can act.
Medical devices range from a low risk device such as a bandage to a high risk device such as implanted pacemakers.
Typical problems with medical devices include:
- deficiencies in labelling, instructions, or packaging
- defective components
- performance failures
- poor construction or design.
Investigations of medical device incidents may lead to regulatory and non-regulatory actions such as product cancellation, recalls, product improvement and user education.