Therapeutic Goods (Medical Devices) Regulations 2002
Overview
The Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) are made under the authority of the Therapeutic Goods Act 1989 and contain the detailed technical and procedural requirements for Australian medical device regulation. They are the primary subordinate legislation for medical devices and are substantially more detailed than the Act itself. The MD Regulations are updated more frequently than the Act — significant amendments in 2021, 2022, 2024, and 2025 have substantially changed manufacturer evidence requirements, classification rules for software and AIMDs, and adverse event reporting.
The current compilation (Compilation No. 63 as at July 2024 — check legislation.gov.au for the most current version) runs to approximately 250 pages excluding schedules.
👉 Therapeutic Goods (Medical Devices) Regulations 2002 — Current text (legislation.gov.au)
Structure of the MD Regulations
The Regulations are divided into Parts and four critical Schedules. The Schedules are where the most-used technical content sits.
Parts — Regulatory and Procedural Content
| Part | Content | Key to |
|---|---|---|
| Part 1 | Preliminary — definitions and application | Definitions of IVD, in-house IVD, active device, etc. |
| Part 2 | Exempt devices | Devices not requiring ARTG inclusion |
| Part 3 | Classification | Classification rules (references to Schedules 2 and 2A) |
| Part 4 | Conformity assessment — applications and certificates | TGA conformity assessment process |
| Part 4A | Australian conformity assessment bodies (CABs) | Australian CAB framework |
| Part 5 | Applications for ARTG inclusion | Manufacturer evidence requirements (Regulation 5.3), application process |
| Part 5A | Annual reporting | Annual report requirements (Regulation 5.7A) |
| Part 6 | Conformity assessment procedures — general | Schedule 3 procedures cross-referenced |
| Parts 6A–6B | Conformity assessment — in-house IVDs | Specific rules for in-house IVD devices |
| Part 7 | Conditions of inclusion | Automatic conditions applying to all ARTG entries |
| Part 8 | Adverse event reporting | Reporting obligations and timeframes (Regulation 5.7) |
| Part 9 | Fees and charges | Application fees, annual charges |
| Part 10 | Miscellaneous | Miscellaneous provisions |
The Four Key Schedules
The Schedules contain the most frequently referenced technical content:
Schedule 1 — Essential Principles
The complete text of all 15 Essential Principles — the safety and performance requirements every device must meet. Divided into:
- Part 1 — General Principles (EP 1–6): apply to all devices
- Part 2 — Design and Construction Principles (EP 7–15): apply case by case
👉 Essential Principles Overview 👉 Schedule 1 — AustLII
Schedule 2 — Classification Rules (General Medical Devices)
The classification rules for all non-IVD medical devices, structured in three Parts:
Part 1 — General classification rules Rules based on invasiveness, duration of use, and anatomical location. These are the rules applied to most passive medical devices and determine Class I, IIa, IIb, or III.
Part 2 — Active device classification rules Rules specific to active medical devices (including software), based on the type of energy delivered or information processed and the potential severity of harm.
Part 3 — Special classification rules Rules that override the general rules for specific device types — including devices containing animal tissues, devices for family planning, and disinfectants.
👉 How Classification Works 👉 Schedule 2 — AustLII
Schedule 2A — Classification Rules (IVD Medical Devices)
The classification rules specifically for in vitro diagnostic medical devices. IVDs are classified (Class 1–4) based on their risk to individual patients and to public health, the analyte being measured, and whether the test is a self-test or point-of-care test.
👉 IVD Class 1–4 👉 Schedule 2A — legislation.gov.au
Schedule 3 — Conformity Assessment Procedures
The detailed conformity assessment procedures that manufacturers must apply. Schedule 3 sets out the specific requirements for each procedure ("Part"):
| Schedule 3 Part | Procedure | Typical use |
|---|---|---|
| Part 1 | Full Quality Assurance | Class IIb, Class III — full QMS including design |
| Part 2 | Type Examination | Product design assessment |
| Part 3 | Verification | Individual or batch production verification |
| Part 4 | Production Quality Assurance | QMS covering production phase |
| Part 5 | Product Quality Assurance | QMS covering product verification (note: being reviewed) |
| Part 6 | Declaration of Conformity | Class I self-certification |
| Part 6A | Procedures for IVDs | IVD-specific conformity assessment |
| Part 7 | Systems and Procedure Packs | SOPPs |
👉 Conformity Assessment Overview 👉 Schedule 3 — legislation.gov.au
Key Individual Regulations
Beyond the Schedules, certain individual regulations are particularly important:
Regulation 3.1–3.3 — Classification Cross-references to Schedule 2 and 2A, and sets out the manufacturer's responsibility for classification.
Regulation 5.3 — Manufacturer evidence The central regulation governing what manufacturer evidence is required for each device class and which overseas regulator certificates are accepted. This regulation was substantially amended in 2024 — always refer to the current version.
Regulation 5.7 — Adverse event reporting The automatic condition of inclusion requiring sponsors to report adverse events and near adverse events to the TGA via IRIS within specified timeframes.
Regulation 5.7A — Annual reporting The requirement for annual reports for Class III, AIMD (now Class III), and certain Class IIb implantable devices.
Regulation 5.8 — Distribution records The requirement to maintain distribution records sufficient to enable an effective recall.
Recent Significant Amendments
| Date | Amendment | Effect |
|---|---|---|
| November 2021 | AIMD reclassification commenced | New active implantable applications classified as Class III |
| July 2021 | Overseas regulator evidence expanded | EU notified body IVDR certificates accepted for IVDs |
| July 2024 | Regulation 5.3 updated | New mandatory audit criteria; EU MDR certificates preferred over MDD for Class III |
| November 2024 | Software classification rules fully effective | All SaMD must be in ARTG; new classification rules apply |
| March 2025 | Healthcare facility reporting | Part 4-8A of Act + supporting regulations commenced |
Official Sources
- MD Regulations 2002 — Current text (legislation.gov.au)
- AustLII — Schedules 1, 2, 3 (easier to read for schedule content)
- TGA — legislation page