Supplying or Manufacturing Medical Devices Containing Poisons in Australia

1. Regulatory Framework Overview

Medical devices containing poisons are regulated under two main frameworks:

• Therapeutic Goods Act 1989 and associated regulations — TGA oversight for safety, quality, and efficacy as medical devices.
• Poisons Standard (Standard for the Uniform Scheduling of Medicines and Poisons — SUSMP) — classifies poisons into Schedules (e.g., S2, S3, S4, S8), with supply controls enforced by state/territory legislation.

Devices incorporating scheduled poisons must satisfy both TGA requirements (e.g., ARTG inclusion) and poisons controls (e.g., authorisation for supply). https://www.tga.gov.au/resources/guidance/supplying-or-manufacturing-medical-devices-containing-poisons

2. Key Definitions and Scope

• Poison — any substance included in the Poisons Standard (SUSMP).
• Medical device containing a poison — a device where the poison is integral (e.g., incorporated in materials, coatings, or as a component) or supplied with the device for use during intended application.

Examples include:

• Silver-containing wound dressings (silver is Schedule 2)
• Devices with local anaesthetics (e.g., lidocaine — Schedule 2 or 4)
• Certain diagnostic agents or disinfectants classified as poisons.

Not all scheduled substances in devices trigger poisons controls — depends on concentration, purpose, and schedule. https://www.tga.gov.au/resources/guidance/supplying-or-manufacturing-medical-devices-containing-poisons

3. TGA Requirements for Inclusion in ARTG

Devices containing poisons must be included in the Australian Register of Therapeutic Goods (ARTG) as medical devices unless exempt.

• Classification follows risk-based rules (Class I to III).
• Conformity assessment evidence required (e.g., ISO 13485, technical documentation).
• Sponsors must declare the presence of scheduled poisons in the ARTG application.

Labelling must comply with TGA requirements, including any poison-specific warnings. https://www.tga.gov.au/resources/guidance/supplying-or-manufacturing-medical-devices-containing-poisons

4. Poisons Legislation and Supply Controls

Supply, possession, and use of scheduled poisons are regulated by state and territory legislation, which adopts the Poisons Standard.

• Schedule 2 (Pharmacy Medicines) — over-the-counter with pharmacist supervision.
• Schedule 3 (Pharmacist Only Medicines) — supplied by pharmacists without prescription.
• Schedule 4 (Prescription Only Medicines) — requires prescription.
• Schedule 8 (Controlled Drugs) — strict controls, including special storage and records.

For devices:

• Sponsors/manufacturers may need a manufacturer’s licence or wholesale licence for poisons in some jurisdictions.
• Supply to healthcare professionals or facilities often requires authorisation (e.g., prescriber endorsement for S4/S8).
• Record-keeping obligations apply for S4 and S8 poisons. https://www.tga.gov.au/resources/guidance/supplying-or-manufacturing-medical-devices-containing-poisons

5. Exemptions and Special Cases

Certain devices may be exempt from poisons controls:

• Devices where the poison is present in concentrations below the cut-off in the Poisons Standard.
• Low-risk devices supplied only to authorised persons (e.g., hospitals).
• Therapeutic goods classified solely as medicines (not devices) — regulated differently.

Custom-made devices and investigational use may have modified requirements. Always confirm with relevant state/territory poisons authority. https://www.tga.gov.au/resources/guidance/supplying-or-manufacturing-medical-devices-containing-poisons

6. Practical Considerations for Sponsors and Manufacturers

• Dual compliance — ensure both TGA and poisons legislation are addressed early.
• Labelling — include any required poison warnings (e.g., “Schedule 4 – Prescription Only”) alongside TGA-mandated information.
• Supply chain — verify downstream users (e.g., hospitals, clinics) hold appropriate authorisations for S4/S8 poisons.
• Record-keeping — maintain detailed records of poison-containing devices supplied, especially for controlled substances.
• Consultation — contact TGA for device classification and state/territory poisons units for supply rules.

Non-compliance with either framework can result in regulatory action, including fines or product removal. https://www.tga.gov.au/resources/guidance/supplying-or-manufacturing-medical-devices-containing-poisons

7. Additional Resources

• Poisons Standard (SUSMP) — full scheduling details.
• State/territory poisons legislation — varies by jurisdiction (e.g., NSW Poisons and Therapeutic Goods Act).
• TGA guidance on borderline products and combination devices.

Sponsors are advised to seek legal or regulatory advice for complex cases involving poisons in medical devices. This guidance was last updated on 22 September 2025. https://www.tga.gov.au/resources/guidance/supplying-or-manufacturing-medical-devices-containing-poisons