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January 14, 2026
Approximately 5 minutes
Supplying Medical Devices in Australia – TGA Regulatory Requirements
Supplying Medical Devices in Australia – TGA Regulatory Requirements
Legal Requirement for Supply
Under the Therapeutic Goods Act 1989, a medical device must be included in the Australian Register of Therapeutic Goods (ARTG) before it can be lawfully imported, exported, or supplied in or from Australia. Supply without ARTG inclusion is generally prohibited unless the device qualifies for an exemption, special access scheme (SAS), Authorised Prescriber (AP) scheme, or clinical trial notification (CTN) pathway. Source: Supply of a medical device - TGA
Pathways to ARTG Inclusion
Most devices require conformity assessment and ARTG entry through one of the following routes:
- Conformity Assessment by TGA: Direct TGA assessment of QMS and technical documentation.
- Overseas Certification Recognition: Acceptance of certain international certificates (e.g., EU MDR certificates during transition, MDSAP).
- Self-Declaration for Low-Risk Devices: Class I non-sterile, non-measuring devices can self-declare conformity.
- Mutual Recognition Arrangements: Limited recognition of assessments from comparable overseas regulators.
Once included in the ARTG, the device receives an ARTG number and can be legally supplied.
Exemptions and Special Supply Mechanisms
Certain devices may be supplied without full ARTG inclusion under:
- Exemptions: Devices used solely for research, custom-made devices (with conditions), or specific low-risk items listed in regulations.
- Special Access Scheme (SAS): Category A (life-threatening conditions) or Category B (other serious conditions) for individual patient use.
- Authorised Prescriber Scheme: For groups of patients with the same condition.
- Clinical Trials: Devices supplied under CTN or CTX schemes.
These mechanisms require sponsor oversight, adverse event reporting, and TGA notification or approval.
Post-Market Supply Obligations
After supply begins, sponsors must:
- Maintain up-to-date ARTG entry information.
- Implement vigilance systems for adverse event reporting and field safety corrective actions.
- Comply with recall procedures if safety issues arise.
- Adhere to advertising and labelling requirements.
- Report changes affecting safety, performance, or intended use to the TGA.
Failure to meet these obligations can result in suspension or cancellation of ARTG inclusion.
Practical Considerations for Sponsors
- Verify ARTG status before any supply activity.
- Ensure distribution chains only handle ARTG-included devices.
- Prepare robust post-market surveillance plans from the outset.
- Monitor regulatory changes, particularly during international transition periods (e.g., EU MDR).
Detailed requirements for ARTG inclusion, exemption criteria, special access pathways, post-market responsibilities, and compliance checklists are outlined in the official TGA guidance on supply of a medical device. Source: Supply of a medical device - TGA
These rules ensure only safe and effective medical devices reach Australian patients while providing controlled access mechanisms for exceptional circumstances.
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