Australia Personalised Medical Devices: Custom-Made and Patient-Matched Rules

1. Key takeaways

Australia has applied its personalised medical devices framework since 25 February 2021. The core changes are a narrowing of the custom-made definition and the addition of the patient-matched medical device (PMMD). The great majority of products previously exempted as custom-made now fall into the PMMD category, which is exempt from inclusion in the ARTG until 1 July 2029. The split between the two categories decides which exemption, which procedure and which deadlines apply, so it is not a labelling exercise. Facts verified as of 29 October 2026.

• The framework commenced on 25 February 2021 through amendments to the Medical Devices Regulations.
• Key definitions sit in regulation 1.3: custom-made device and patient-matched medical device (PMMD).
• Unconditional PMMD exemption: Schedule 4 Part 1 item 1.7, limited by regulation 7.1(8) to the first 5 devices per manufacturer per financial year.
• Conditional PMMD exemption: Schedule 4 Part 2 item 2.14, running until 1 July 2029, with a written notice to the TGA due before 1 November 2024.
• Custom-made devices follow Schedule 3 Part 7 regulation 7.2 (special purpose procedures); MDPS remains dormant pending a future legislative instrument.

2. Legal basis

The framework is built from the definitions in the Regulations, the exemption items in Schedule 4, and the procedure for special purpose devices in Schedule 3 Part 7. Because the definitions are detailed, the classification decision should be documented against the exact regulatory language.

• Commencement of the framework: 25 February 2021, introduced by amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237).
• Key definitions (regulation 1.3 interpretation): a custom-made device is one made for a singular patient or for use by a particular health practitioner in their practice, incorporating specific design characteristics stated in a written request of that health practitioner (the design may be developed in consultation with the manufacturer); a patient-matched device (PMMD) is one manufactured within an established design envelope to match a specific individual’s anatomy, physiology or pathological state, designed by the manufacturer (who may consult the health practitioner), and produced using processes that are verifiable and validated.
• PMMD exemptions and conditions: Schedule 4 Part 1 item 1.7 (unconditional exemption, and per regulation 7.1(8) the exemption applies only to the first 5 devices per manufacturer per financial year); Schedule 4 Part 2 item 2.14 (conditional exemption, until 1 July 2029); the sponsor must have notified the TGA in writing, before 1 November 2024, of each kind of PMMD it intends to supply in Australia on and after 1 July 2029.
• Procedure for custom-made devices: Schedule 3 Part 7 regulation 7.2 (special purpose procedures) — the manufacturer must prepare a written statement (patient name, requesting doctor’s name and address, design characteristics, a statement of compliance with the essential principles or an explanation of non-compliance), supply it with the device, and keep design, production and intended performance documents; where an event associated with death or serious deterioration in health occurs, the Secretary must be notified as soon as practicable.
• Overseas-manufactured custom-made devices: the sponsor must provide the Secretary with device information within 2 months after first import (Schedule 4 Part 2 item 2.13).
• Custom-made devices manufactured in Australia: Schedule 4 Part 2 item 2.12.
• Medical device production systems (MDPS): the definition already exists in the Regulations, but it takes effect only when a future legislative instrument declares MDPS to be medical devices (that work remains in progress).

3. Expert insights

Insight 1: the 1 November 2024 notification deadline has passed, but its consequences live on. For PMMDs not notified before 1 November 2024, the legal basis for continued supply after 1 July 2029 is in doubt. Making the notification now is the only viable remedial step — late notification does not restore the pre-deadline position, but it does preserve whatever continuity of supply argument remains available under the conditional exemption. Where supply runs through intermediaries, the notification record should name the kinds precisely, so later product variations do not fall outside the notified scope.

Insight 2: the first-5-devices-per-year cap is an operating variable. Regulation 7.1(8) confines the unconditional exemption to the first 5 devices the manufacturer produces in each financial year. Volumes beyond that need the conditional exemption or ARTG inclusion, and production capacity planning must account for the cap; a scaling business can move out of the exemption purely through growth, without any change in the product itself. The count should be visible to sales and production teams alike, since exceeding it usually happens through routine order intake rather than a deliberate decision.

Insight 3: MDPS is a variable that has not yet landed. The definitions for 3D printing equipment and “medical device production systems” are already in the Regulations, but they take effect only when a legislative instrument declares them medical devices. Point-of-care manufacturing businesses need to track this closely, because it could restructure who bears which obligations at the point of production. Engaging with the framework now, while MDPS is dormant, is cheaper than restructuring point-of-care operations after an instrument lands.

4. Practical recommendations

• Classify every personalised product against the regulation 1.3 definitions — custom-made or PMMD — and derive the procedure or exemption item from that classification.
• For PMMDs to be supplied after 1 July 2029, make the notification to the TGA now if not already made, and keep proof of delivery.
• Maintain a counting ledger for the “first 5 devices per financial year” exemption and plan alternative pathways ahead for volumes beyond it.
• For custom-made products, build the written statement template and document retention system per Schedule 3 Part 7 regulation 7.2, and rehearse the serious event notification path with the clinical team.

5. Verification checklist

• □ Classification of custom-made versus PMMD completed against the regulation 1.3 definitions
• □ PMMD notification obligation discharged (original deadline 1 November 2024)
• □ A counting ledger for the first-5-devices-per-financial-year exemption is in place
• □ The regulation 7.2 written statement template is ready for custom-made products
• □ A 2 months after first import notification point is set for overseas-manufactured custom-made devices
• □ Progress of the MDPS legislative instrument is being tracked

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team manages TGA ARTG inclusion across all classes, prepares conformity assessment dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanlang.com