On July 26, 2019 the TGA has released a Version V1.3 of its guidance “Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)”. Overseas evidence that can be considered now list EU ISO 13485:2016 certificates and gives further clarification on their acceptability:
According to TGA, the agency will keep a close eye on the readiness and availability of Notified Bodies in Europe and will consider further amendments in Australia, if necessary.
TGA: News room
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