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TGA Publishes updated MDIR Guide

By Grant Bennett | 10.31.2019
Last week, the Australian regulator, the Therapeutic Goods Administration (TGA) published an updated guidance for Australian Sponsors and Manufacturers for the reporting of adverse events in Australia (Medical device incident...
Gandalf

New Zealand WANDers towards increased device regulation

By Arthur Brandwood | 12.21.2018
If you are WANDering about the title of this blog, yes, it’s a dreadful pun I know – but it’s that time of year. New Zealand’s Medsafe have issued a...
Uncertainty

Risk vs. Benefit FDA guidance gets to grips with uncertainty

By Arthur Brandwood | 09.27.2018
Doing risk management in an uncertain world is why regulatory affairs are as much art as science. Innovators will continue to push the envelope of the possible while regulators will...

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Recent Posts

Are Harmonised Standards facing irrelevance?

Nov 4, 2019

The question on clients’ lips… “How long will my application take?”

Nov 4, 2019

TGA Publishes updated MDIR Guide

Oct 31, 2019

EU Software Classification under MDR/IVDR – New Guidance Document

Oct 28, 2019

Out They Go – FDA Clears the Store of Guidances

Oct 25, 2019

FDA Fashion Parade – Guidance Priorities for Fiscal 2020

Oct 25, 2019

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