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Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
This Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).
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 is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
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GuidanceGuidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.
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GuidanceThis Guidance explains how overseas assessments can support our medical device certification and registration processes.