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Australia Therapeutic Goods (Medical Devices) Regulations 2002

What is Australia Therapeutic Goods (Medical Devices) Regulations 2002?

Australia's Therapeutic Goods (Medical Devices) Regulations 2002: the essential principles, classification rules and conformity assessment procedures for medical devices and IVDs, the automatic conditions on ARTG entries (adverse event reporting periods, complaint and distribution records, annual reports), exemption and clinical trial conditions, mandatory healthcare facility reporting and the unique device identification rules. It comprises 67 controls organised across 10 domains, and applies in Australia.

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Where Australia Therapeutic Goods (Medical Devices) Regulations 2002 overlaps with the standards you already hold

Australia Therapeutic Goods (Medical Devices) Regulations 2002 vs ISO 27001:2022View comparison →Australia Therapeutic Goods (Medical Devices) Regulations 2002 vs SOC 2View comparison →Australia Therapeutic Goods (Medical Devices) Regulations 2002 vs NIST CSF 2.0View comparison →Australia Therapeutic Goods (Medical Devices) Regulations 2002 vs GDPRView comparison →Australia Therapeutic Goods (Medical Devices) Regulations 2002 vs HIPAAView comparison →Australia Therapeutic Goods (Medical Devices) Regulations 2002 vs PCI DSS 4.0View comparison →

What Australia Therapeutic Goods (Medical Devices) Regulations 2002 means in your sector

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What Australia Therapeutic Goods (Medical Devices) Regulations 2002 means for your job

Australia Therapeutic Goods (Medical Devices) Regulations 2002 for CISOs→Australia Therapeutic Goods (Medical Devices) Regulations 2002 for Compliance Officers→Australia Therapeutic Goods (Medical Devices) Regulations 2002 for Risk Managers→Australia Therapeutic Goods (Medical Devices) Regulations 2002 for IT Directors→Australia Therapeutic Goods (Medical Devices) Regulations 2002 for DPOs→Australia Therapeutic Goods (Medical Devices) Regulations 2002 for Auditors→

Questions people ask about Australia Therapeutic Goods (Medical Devices) Regulations 2002

What is Australia Therapeutic Goods (Medical Devices) Regulations 2002?
Australia's Therapeutic Goods (Medical Devices) Regulations 2002: the essential principles, classification rules and conformity assessment procedures for medical devices and IVDs, the automatic conditions on ARTG entries (adverse event reporting periods, complaint and distribution records, annual reports), exemption and clinical trial conditions, mandatory healthcare facility reporting and the unique device identification rules.
How many controls does Australia Therapeutic Goods (Medical Devices) Regulations 2002 have?
Australia Therapeutic Goods (Medical Devices) Regulations 2002 contains 67 controls organized across 10 domains.
Where does Australia Therapeutic Goods (Medical Devices) Regulations 2002 apply?
Australia Therapeutic Goods (Medical Devices) Regulations 2002 applies in Australia. Organizations operating in or serving customers in this jurisdiction should check whether its requirements reach them.
Which version of Australia Therapeutic Goods (Medical Devices) Regulations 2002 is covered here?
This page covers Compilation No. 72 (F2026C00883), compilation date 8 September 2026, registered 11 September 2026, incorporating amendments up to the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 (F2026L01167).

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Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .