Conformity Assessment

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TGA deploys Post Market Review Compliance Dashboard

Under the Therapeutic Goods Act 1989, it is mandatory for sponsors and manufacturers to report adverse events that have, or could have, led to death, serious illness or injury to...
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TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

On 13 October 2020, the TGA specified that it will take a broader view in the case that companies suffer a lapse on renewing their Conformity Assessment Documents in response...
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New Zealand WANDers towards increased device regulation

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...

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