Dec 9, 2021
Australia and Oceania
The second article provides an in-depth review of the TGA application form and describes the way the submitter should provide information about the applicant entity and the medical device(s) subject to review. The Therapeutic Goods Administration (TGA), an Australian...
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Dec 2, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to applying for consent to import, supply, or export a medical device that does not comply with the...
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Nov 17, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document describes in detail the procedures to be followed...
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Nov 15, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published a document providing examples of regulated and unregulated software and software-based medical devices. The document is intended to assist...
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Oct 4, 2021
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a guidance document dedicated to software for use with COVID-19 rapid antigen self-tests. Apart from other aspects, the document describes...
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