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
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.

Read the legislation

Guidance referring to this legislation

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

23 October 2024

Guidance

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

Sub menu

Therapeutic Goods (Overseas Regulators) Determination 2018

Official version of legislation

Guidance referring to this legislation

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

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

Help us improve the Therapeutic Goods Administration site

Site notifications

Therapeutic Goods (Overseas Regulators) Determination 2018

Official version of legislation

Guidance referring to this legislation

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

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

Help us improve the Therapeutic Goods Administration site