Dec 15, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has published a guidance document describing the priority applicant determination criteria and process for all types of medical devices including the ones intended for in vitro diagnostics (IVDs). The present...
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Oct 22, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has published a notice describing the approach to delays in medical device conformity assessment recertification. The document is intended to address the issues related to the outbreak of COVID-19 caused by the...
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Oct 7, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA), the medical device regulating authority, has published a final consultation paper dedicated to the Australian Unique Device Identification (UDI) System to be implemented in the country in the course of the ongoing...
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Oct 5, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has provided public consultations on reporting adverse events associated with medical devices. The document describes the new approach to adverse event reporting to be implemented to improve communication among...
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Sep 2, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA) provided a set of detailed guidance documents to assist medical device manufacturers in achieving and sustaining compliance with regulatory requirements to be allowed for marketing in Australia – the Australian...
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