Overview of Medical Devices and IVD Regulation in Australia – TGA Framework

Regulatory Authority and Legal Basis

The Therapeutic Goods Administration (TGA), part of the Australian Government Department of Health and Aged Care, administers the Therapeutic Goods Act 1989 and associated regulations. Medical devices and IVDs are regulated as therapeutic goods to ensure they meet acceptable levels of safety, quality, and performance before and after supply in Australia. Source: Overview of medical devices and IVD regulation - TGA

Definition and Scope

• Medical Device: Any instrument, apparatus, appliance, material, or other article (including software) intended for human use in diagnosis, prevention, monitoring, treatment, or alleviation of disease/injury, or modification of anatomy/physiology, without primarily achieving its action by pharmacological/chemical/immunological means.
• IVD Medical Device: A device intended for in vitro examination of specimens from the human body (e.g., blood, tissue) to provide information on physiological state, health, or disease.

Both are regulated under the same framework but with specific classification rules for IVDs.

Risk-Based Classification System

Devices are classified according to the level of potential harm and intended use (Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002):

• Class I: Low risk (e.g., non-invasive, low microbial hazard)
• Class IIa: Low-medium risk (e.g., invasive short-term, active low-risk)
• Class IIb: Medium-high risk (e.g., invasive long-term, active medium-risk)
• Class III: High risk (e.g., implantable, active life-supporting)

IVDs follow a separate four-class system (Class 1 to Class 4), with Class 4 representing highest individual and public health risk (e.g., HIV screening tests).

Conformity Assessment and ARTG Inclusion

• Manufacturers must demonstrate conformity with Essential Principles (safety/quality/performance) via appropriate procedures based on classification.
• Higher classes generally require third-party certification (e.g., by TGA or notified bodies under EU-recognized schemes).
• Once conformity is established, devices are included in the ARTG, enabling legal supply.
• Class I non-sterile, non-measuring devices may self-certify with lower evidence requirements.

Post-Market Responsibilities

• Mandatory adverse event reporting
• Ongoing monitoring of performance and safety
• Recall or hazard alert procedures when issues arise
• Annual ARTG entry charges and compliance audits

Special Categories and Exemptions

• Some low-risk devices (e.g., certain Class I) are exempt from inclusion but must still comply with advertising and labelling rules.
• Custom-made devices and systems/devices intended for export only have specific provisions.

This risk-proportionate framework aligns Australia with international best practices (IMDRF) while protecting public health. Detailed classification rules, Essential Principles checklists, conformity assessment pathways, and ARTG application guidance are available in the official TGA overview of medical devices and IVD regulation. Source: Overview of medical devices and IVD regulation - TGA