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.
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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.
Guidance referring to this legislation
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GuidanceThis Guidance explains how overseas assessments can support our medical device certification and registration processes.
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GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.