The Australian Sponsor System: Statutory Duties of the Responsible Party

1. Key takeaways

The responsible party in Australia is the sponsor, not the manufacturer. The definition of sponsor is in section 3(1) of the Therapeutic Goods Act 1989, and it expressly excludes a person who does any of those things on behalf of another person resident in Australia or carrying on business in Australia — this carve-out is decisive for whether an overseas manufacturer can act as the sponsor itself. Reading the definition carefully before contracts are signed avoids structuring responsibilities around an entity the Act does not recognise as sponsor. Facts verified as of 29 October 2026.

• Sponsor is defined in section 3(1): the person who exports or arranges the export, imports or arranges the import, or manufactures or arranges the manufacture in Australia.
• The definition excludes persons acting on behalf of another person resident in, or carrying on business in, Australia.
• The conditions attached to ARTG inclusion (section 41FN) take effect automatically — no separate notice from the TGA is needed.
• Manufacturer and sponsor failures to apply conformity assessment procedures are split across two sections: 41ME and 41MF.
• The TGA expects the sponsor to be a “recognised Australian-based legal entity”, per its Medical device inclusion process page (23 November 2023), which is also the practical reference for entity setup.

2. Legal basis

Sponsor obligations arise partly from the Act and partly from the Regulations, and several of them attach automatically the moment a device is included in the ARTG. These duties also feed the evidence set for ARTG inclusion, so aligning them early saves rework, and they cannot be delegated away by contract.

• Therapeutic Goods Act 1989 (Act No. 21, 1990, compilation C2004A03952): the definition of sponsor is in section 3(1) — a person who exports the goods, or arranges their export, from Australia; imports, or arranges the import of, the goods into Australia; or manufactures, or arranges the manufacture of, the goods in Australia; but not including a person who does any of those things on behalf of another person resident in Australia or carrying on business in Australia. The definition of manufacturer is in section 41BG(1)–(4).
• Responsibility-splitting provisions: failure by the manufacturer to apply conformity assessment procedures is dealt with in section 41ME; failure by the sponsor in section 41MF.
• Automatic conditions (effective upon inclusion in the ARTG): section 41FN — 41FN(1) allows authorised persons to enter premises to inspect and take samples; 41FN(2) requires delivery of samples on request; 41FN(3) covers availability of information (including 41FN(3)(d), reporting of certain events and performance issues); 41FN(5) covers advertising materials.
• Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): adverse event reporting, regulation 5.7; investigation reports, regulation 5.8A; record keeping, regulation 5.10; annual reports, regulation 5.11; sponsor information to be supplied with the device, regulation 10.2.
• TGA official position: the sponsor must be a “recognised Australian-based legal entity”, per the TGA page “Medical device inclusion process” (23 November 2023).

3. Expert insights

Insight 1: the exclusion in section 3(1) decides the position of overseas manufacturers. If an overseas manufacturer imports into, or arranges the import of goods into, Australia “on behalf of” an Australian principal, then under the exclusion it is not the sponsor; the real sponsor is the Australian principal who commissioned the act. This point is often overlooked, with the result that agreements place responsibility on an entity that is legally not the sponsor — a structure that will not survive scrutiny when an enforcement or recall scenario materialises. Where the Australian principal is the true sponsor, the import paperwork, the ARTG entry and the post-market duties all belong to that principal, whatever the commercial arrangement says.

Insight 2: the automatic conditions take effect without any separate notification. The conditions in section 41FN attach automatically upon inclusion, with no separate instrument from the TGA. This means that at the very moment a company receives its ARTG number, the duties to cooperate with inspection, deliver samples, make information available and report specified matters are already live. Compliance planning that starts “after registration” is, in legal terms, already late. A practical consequence is that the sponsor should stand up its post-market processes before the ARTG number is issued, since there is no grace period to speak of.

Insight 3: sponsor duties and manufacturer duties sit in separate provisions. Sections 41ME and 41MF respectively govern failures by the manufacturer and by the sponsor to apply the conformity assessment procedures. This structure of two duty-holders with separate provisions is the legal foundation for allocating responsibilities when drafting an authorised representative agreement (see article 33 of this series for the detailed treatment). Where one entity holds both roles for a product, both sets of provisions apply cumulatively, and internal responsibility assignments should reflect that doubling.

4. Practical recommendations

• Complete a statutory determination of sponsor identity before signing the agreement, and confirm that no section 3(1) exclusion applies.
• Build an “automatic conditions compliance checklist” that breaks section 41FN down into executable actions (premises access, sample delivery, information availability, reporting triggers), with a named contact for TGA requests and a defined response time.
• In the written agreement with the manufacturer, bind the regulation 5.2 20 working day information-obtaining obligation and the section 41FN(3) information availability duty to the same responsible party.
• The sponsor’s name and address must be supplied with the device under regulation 10.2; when they change, update the labelling and instructions for use at the same time.

5. Verification checklist

• □ Statutory determination of sponsor identity completed, confirming no section 3(1) exclusion applies
• □ A compliance checklist for each paragraph of section 41FN has been established
• □ The agreement with the manufacturer binds the 20 working day information-obtaining obligation
• □ Labelling and instructions for use state the sponsor’s name and address (regulation 10.2)
• □ Responsible parties have been configured separately for section 41ME and section 41MF duties

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