Therapeutic Goods Act 1989
Overview
The Therapeutic Goods Act 1989 (the Act) is the primary legislation governing all therapeutic goods in Australia, including medical devices. It is an Act of the Australian Parliament and sits at the top of the regulatory hierarchy — all regulations, instruments, and guidance documents derive their authority from it. When there is any conflict between the Act and a subordinate instrument, the Act prevails.
The Act is administered by the Therapeutic Goods Administration (TGA), which is part of the Department of Health, Disability and Ageing. The current compilation of the Act (Compilation No. 88, dated 21 March 2025) incorporates all amendments to that date, including the March 2025 amendments introducing mandatory healthcare facility adverse event reporting.
👉 Therapeutic Goods Act 1989 — Current text (legislation.gov.au)
Structure of the Act
The Act is divided into eight Chapters. Medical device provisions are primarily in Chapter 4, but several other Chapters also apply to devices:
| Chapter | Content | Relevance to Devices |
|---|---|---|
| Chapter 1 | Preliminary — definitions, objects | Definitions of key terms including "medical device" (s41BD), "manufacturer" (s41BG), "sponsor" |
| Chapter 2 | Australian Register of Therapeutic Goods (ARTG) | The ARTG itself — Section 9A establishes and maintains it |
| Chapter 3 | Medicines and biologicals | Generally not applicable to medical devices |
| Chapter 4 | Medical devices | The core chapter — see breakdown below |
| Chapter 5 | Advertising, counterfeit goods, tampering | Advertising offences and requirements apply to devices |
| Chapter 5A | Enforcement | Infringement notices, civil penalties, injunctions |
| Chapter 6 | Administration | TGA's administrative powers, entry and search |
| Chapter 7 | Miscellaneous | General provisions |
| Chapter 8 | Repeal and transitional | Transitional arrangements |
Chapter 4 — Medical Devices in Detail
Chapter 4 contains all the substantive medical device provisions. It is divided into Parts:
Part 4-1 — Preliminary (Definitions)
Part 4-1 contains the foundational definitions for the medical device framework. Key sections:
Section 41BD — Definition of a medical device The legal definition of a medical device, based on intended purpose and the means by which the device achieves its purpose (physical, mechanical, or chemical, not primarily pharmacological, immunological, or metabolic).
Section 41BE — Meaning of "kind of medical device" Defines what constitutes a single "kind" of device for ARTG purposes — relevant to how many ARTG entries a sponsor needs.
Section 41BF — Meaning of "system or procedure pack" Defines systems and procedure packs for regulatory purposes.
Section 41BG — Meaning of "manufacturer" Defines who is the manufacturer of a medical device — the person who designs, produces, or assembles the finished device and places it on market under their own name.
Part 4-2 — Essential Principles
Section 41DN — Requirement to comply with Essential Principles Every medical device supplied in Australia must comply with the Essential Principles in Schedule 1 of the MD Regulations. Non-compliance is a criminal offence.
Section 41DO — Meaning of compliance with Essential Principles Sets out what compliance with the Essential Principles means — including compliance with applicable standards.
👉 Essential Principles Overview
Part 4-3 — Conformity Assessment
Section 41EA — Requirement for conformity assessment Manufacturers must apply conformity assessment procedures appropriate to the device class.
Section 41EB — Conformity assessment certificates The TGA's power to issue conformity assessment certificates and the conditions applying to them.
Part 4-4A — Australian Conformity Assessment Bodies (CABs): the framework for approved Australian third-party assessment bodies.
👉 Conformity Assessment Overview
Part 4-5 — Including Medical Devices in the Register
This is the Part governing ARTG inclusion — the core of the pre-market framework.
Section 41F — Overview of Part 4-5 Explains the structure of the ARTG inclusion regime.
Section 41FA — Applying to include a device in the ARTG Requirements for ARTG inclusion applications — who can apply (sponsors only), what must be included.
Section 41FC — Duration of inclusion ARTG entries are granted for the life of the device unless cancelled or suspended.
Section 41FH — Suspension of ARTG entries The TGA's power to suspend an ARTG entry where safety concerns arise.
Section 41GM / 41GN — Cancellation of ARTG entries The TGA's power to cancel an ARTG entry — after a notice process in most cases.
Part 4-6 — Exemptions from ARTG Inclusion
Section 41HA — Exempt devices Devices that are exempt from ARTG inclusion requirements — including devices for personal use, export-only devices (under certain conditions), devices used in clinical trials (under CTN/CTA), and custom-made devices.
Section 41HB — Special Access Scheme approvals The Secretary's power to approve supply of unapproved devices for specific patients (SAS pathway).
Part 4-8 — Obtaining Information
The TGA's powers to require sponsors and manufacturers to provide information, including technical documentation, within specified timeframes. This is the legislative basis for the TGA's power to require technical files during application audits and post-market compliance reviews.
Part 4-8A — Mandatory Reporting by Healthcare Facilities (from March 2025)
Section 41JK — Simplified outline Provides the overview of the mandatory healthcare facility reporting regime.
Section 41JM — Requirement to report adverse events The CEO of a healthcare facility must report adverse events involving reportable medical devices to the TGA. The staged implementation commenced March 2025.
Part 4-9 — Public Notification and Recall
Section 41K — Overview The TGA's powers in relation to public notification and recall of medical devices.
Section 41KA — Public notification and recall powers The TGA can require sponsors to recall devices, issue public warnings, and take other protective actions.
Section 41GN — Mandatory recall directions The TGA can direct a sponsor to recall a device where it is satisfied the device has caused or may cause harm.
Part 4-11 — Offences and Penalties
This Part contains criminal offences for supplying devices that do not comply with the Essential Principles, supplying devices without ARTG inclusion, false statements in applications, and other serious non-compliance. Maximum penalties are substantial — up to 5 years imprisonment and/or 5,000 penalty units for the most serious offences.
Key Penalty Units (2025)
A penalty unit in Australia is currently $330 (indexed annually). So:
- 5,000 penalty units = $1,650,000 maximum civil penalty
- Criminal penalties of up to 5 years imprisonment apply for the most serious supply offences
Recent Amendments
Compilation No. 88 (21 March 2025) The most recent compilation incorporates the mandatory healthcare facility adverse event reporting amendments (Part 4-8A) introduced by the Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023, with supporting regulations commencing March 2025.
How to Read the Act
The Act uses a system of Notes and simplified outlines at the beginning of each Part and Chapter to help readers understand the structure. These are not legally operative — they are navigation aids only. The operative provisions are in the numbered sections.
Cross-references between the Act and the MD Regulations are frequent — understanding a provision in the Act often requires reading the corresponding regulation, and vice versa.