Katerina Giannelis

Checklist

Australia’s TGA releases updated Essential Principles Checklist

In Australia, for any given device, irrespective of risk classification, manufacturers must demonstrate compliance with the Therapeutic Goods Administration (TGA) essential principles. The essential principles define the requirements for the...
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Alternative Pathways for Medical Device Market Authorisation

It is no question that in order to obtain market authorisation to import, manufacture and sell a medical device, manufacturers or applicants must adhere to the jurisdiction-specific regulations. Despite this,...

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