Therapeutic Goods (Medical Devices) Regulations 2002

This legislation sets out the detailed rules for how medical devices are regulated in Australia. It covers:

What it does:

• Classifies medical devices into risk-based categories (Class I, IIa, IIb, III for general devices; Class 1-4 for in-vitro diagnostic/IVD devices). Higher classes mean higher risk and stricter requirements.
• Sets conformity assessment procedures — the steps manufacturers must take to prove their devices are safe and effective before they can be sold in Australia.
• Establishes the Australian Unique Device Identification Database — a system to track medical devices using unique identifiers, similar to a barcode system for medicines.
• Creates a framework for Australian conformity assessment bodies — organisations that can certify medical devices meet Australian standards.
• Provides exemptions for certain devices used in emergencies, clinical trials, or by individual medical practitioners for seriously ill patients.
• Sets fees and charges for applications, assessments, and inclusion in the Register (Australia's list of approved medical devices).

Who it affects:

• Manufacturers of medical devices (both Australian and overseas)
• Sponsors — the Australian entities responsible for importing and supplying devices