Therapeutic Goods (Overseas Regulators) Determination 2018

This Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.

Official version of legislation
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Guidance referring to this legislation

Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs)

13 November 2023

Guidance

This Guidance explains how overseas assessments can support our medical device certification and registration processes.
Transitioning to new manufacturer evidence for in-vitro diagnostic medical devices (IVDs)

1 November 2023

Guidance

This guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.

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Therapeutic Goods (Overseas Regulators) Determination 2018

Official version of legislation

Guidance referring to this legislation

Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs)

Transitioning to new manufacturer evidence for in-vitro diagnostic medical devices (IVDs)

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