TGA Process for Conformity Assessment in Australia


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As we watch the changes in Europe evolve under the Medical Devices Regulations (MDR), we are starting to see an increasing trend where companies that had previously used Europe as a fast pass into Australia, starting to go directly to the Therapeutic Goods Administration (TGA) for their conformity assessment. Previously, we saw the agency struggling to meet their specified timelines, and sometimes, taking well over one year before you’d see an approval. 

Over the last few years and multiple reviews, there has been a focused effort by the TGA to not just throw additional resources at the problem but they’ve spent more time in developing their internal processes and systems. That, in turn, has led to a reduction in the time taken across all facets of the medical device registration process.


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Grant Bennett is CEO of Brandwood Biomedical and provides expert consultancy services relating to regulatory compliance in Australia, New Zealand and the Asia-Pacific. Grant is also responsible for management oversight of all Australian consulting projects.


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