Day: September 3, 2018

Brandwood Biomedical global experts medical devices regulatory affairs consulting medical devices IVDs Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China Taiwan Hong Kong Europe New Zealand United States

TGA join the electronic age with electronic IFU

Last week saw an increased number of guidance’s released by the Australian regulator, the Therapeutic Goods Administration (TGA). This included a new guidance on Electronic Instructions for Use – eIFU...
Brandwood Biomedical global experts medical devices regulatory affairs consulting medical devices IVDs Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China Taiwan Hong Kong Europe New Zealand United States

TGA issues international collaboration guidelines for review of pharma applications

New guidelines for collaboration with overseas regulators were issued on June 15th 2018 by the TGA. Australia’s Therapeutic Good Administration (TGA) has issued a guidance for a framework to enable...
Brandwood Biomedical global experts medical devices regulatory affairs consulting medical devices IVDs Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China Taiwan Hong Kong Europe New Zealand United States

Marketing in a regulated market

Last month, the Brandwood Biomedical team had the privilege of presenting at the ARCS conference here in Sydney. This gave me an opportunity to speak about one of my dearest...

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