Manufacturer and Sponsor: Split Responsibilities in Australia

1. Key takeaways

Australia operates a “dual-entity, split-responsibility” structure between manufacturer and sponsor: the manufacturer’s duties are set out in sections 41BG and 41ME of the Therapeutic Goods Act 1989, while the sponsor’s duties are set out in section 41MF. The agreement between the two parties must translate the evidence-availability duty of section 41FN(3) into enforceable clauses; otherwise the sponsor is left holding statutory obligations it cannot perform.

• Manufacturer duties and sponsor duties are separate statutory tracks, not a shared pool.
• Section 41FN(3) allows the sponsor to rely on a written agreement with a 20 working days evidence turnaround.
• Regulation 5.2 fixes the matching 20 working days period on the regulations side.
• Regulations 5.10, 5.11 and 5.7 supply the record and reporting framework on top.
• The manufacturer definition includes supply under a person’s own name, which catches OEM arrangements.
• Inspection cooperation extends to overseas premises and must be contractually secured.

Reading the two tracks side by side also clarifies where the paperwork belongs. The manufacturer’s obligations live mainly in conformity assessment and design documentation; the sponsor’s obligations live mainly in information, records and reporting. An agreement that copies one track onto both parties creates duplicated duties without reducing either party’s statutory exposure.

2. Legal basis

The provisions below locate each duty on the Act or on the regulations, and identify the clause that turns them into contract terms.

1. Therapeutic Goods Act 1989 (Act No. 21, 1990): the definition of manufacturer appears in section 41BG(1)–(4) — a person responsible for the design, production, packaging and labelling of the device who supplies it under that person’s own name; failure by the manufacturer to apply conformity assessment procedures is addressed in section 41ME; failure by the sponsor in section 41MF.
2. The sponsor’s evidence-availability duty: section 41FN(3) — evidence of conformity with the essential principles must be held at all times, or a written agreement with the manufacturer must ensure it can be obtained within 20 working days of a request; paragraph 41FN(3)(d) also requires the reporting of certain events and performance issues.
3. The matching period on the regulations side: Therapeutic Goods (Medical Devices) Regulations 2002, regulation 5.2 — prescribes a period of 20 working days for the purposes of paragraphs 41FD(e)(ii) and 41FD(g)(ii) of the Therapeutic Goods Act 1989.
4. Inspection and sampling cooperation: section 41FN(1) (entry into premises) and section 41FN(2) (supply of samples, notice period of at least 10 working days).
5. Records and reporting: regulation 5.10 (distribution records), regulation 5.11 (annual reports) and regulation 5.7 (adverse event reporting).
6. Labelling: regulation 10.2 — the sponsor’s name and address must accompany the device.

3. Expert insights

Insight 1: section 41FN(3) is the pivot of agreement design. It allows the sponsor to substitute “written agreement plus 20 working days” for “holding the evidence at all times”. This is at once a pressure-relief valve for the sponsor and a source of performance obligations for the manufacturer. Without that clause in the agreement, the sponsor must hold all evidence itself. For an overseas manufacturer this clause is also the cheapest way to protect the relationship: without it, every audit request from TGA lands on the sponsor, who then forwards it with delay, and every delay counts against the statutory 20 working days clock.

Insight 2: the manufacturer definition includes supply under a person’s own name. Section 41BG treats “under whose name the device is supplied” as one of the elements for identifying the manufacturer. In OEM/ODM relationships, the party lending its name may be treated as the manufacturer — a result that differs from the intuitive understanding common among Chinese enterprises. The practical test is therefore not who physically produces the device but whose name the market sees on the label, and that question should be settled before the inclusion application is drafted.

Insight 3: the inspection cooperation duty extends to overseas premises. Section 41FN(1) allows authorised persons to enter premises. The agreement must expressly state the manufacturer’s cooperation duty for overseas sites; otherwise the sponsor cannot perform the automatic conditions. Overseas factories should be listed in the agreement with named contacts and an agreed inspection window, so that a TGA visit never depends on ad hoc goodwill.

A closing observation: the split-responsibility structure rewards parties who document their interface. Where the agreement states precisely which party receives TGA correspondence, which party classifies adverse events and which party maintains which register, the statutory allocation of sections 41ME and 41MF is merely confirmed on paper; where the interface is silent, every incident forces an improvised negotiation while the statutory clocks continue to run.

4. Practical recommendations

• Include six clauses as standard in the agreement: (1) a 20 working days commitment on the provision of information; (2) cooperation with inspection of overseas premises; (3) sample delivery against the 10 working days notice period; (4) immediate notification of adverse events and performance issues; (5) handover of distribution and complaint records; (6) handover of evidence and disposition of entries on termination.
• State clearly under whose name each party supplies the device, to avoid misjudging identity in OEM relationships.
• Agree which party holds evidence and for how long, matching the 10-year and 5-year tiers of regulation 5.10.
• Run an annual performance review of the agreement, focused on whether any information request was ever answered late.

5. Verification checklist

• □ The agreement contains the section 41FN(3) commitment of 20 working days for information provision
• □ The cooperation duty for inspection of overseas premises is expressly stated
• □ The sample delivery clause matches the 10 working days notice period
• □ A notification mechanism for adverse events and performance issues is in place
• □ The nominal manufacturer is identified as required by section 41BG
• □ Custody and retention periods for evidence are agreed

Regulatory information verified as of 29 October 2026

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 coordinates Australian sponsor arrangements, ARTG annual charges, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com