In this article
The manufacturer’s roleThe sponsor’s roleWhat the consumer seesWhy accountability does not end at purchaseExample: putting the information in contextWhat to check nextFrequently asked questionsIs the sponsor always the manufacturer?Who should a patient contact about a fault?Read more on this topicOfficial sourcesRelated articles
The manufacturer and the Australian sponsor have related but different responsibilities for a medical device. Understanding the distinction helps consumers know whose name appears on an ARTG entry and who to contact about a safety notice.
The manufacturer’s role
The manufacturer is responsible for design and manufacture, and for demonstrating compliance with applicable safety and performance requirements. This can include risk management, quality processes, evidence, labelling and appropriate controls over technical changes.
The sponsor’s role
An Australian sponsor is the party responsible for particular importation or supply obligations in Australia. The sponsor generally maintains regulatory relationships with the TGA, needs access to manufacturer evidence and has ongoing post-market responsibilities. The sponsor is not necessarily the same company that built the product.
What the consumer sees
The ARTG record may identify both sponsor and manufacturer. Packaging, instructions and notices can also identify contact channels. If a device is subject to a market action, follow official instructions and contact the responsible supplier or sponsor using verified details.
Why accountability does not end at purchase
Adverse event reporting, changes to registered details, recordkeeping and responses to safety concerns can continue for as long as the device is supplied. A retailer’s warranty service and the sponsor’s regulatory obligations are different issues.
Example: putting the information in context
A device is made in one country and supplied into Australia by an Australian company. The public ARTG entry identifies the relevant sponsor. A patient reports a malfunction to their pharmacist and the sponsor may need to investigate or communicate with the TGA.
What to check next
- Identify the manufacturer and Australian sponsor on the official record.
- Use verified supplier or sponsor channels for safety enquiries.
- Retain the model and batch details when reporting a problem.
Frequently asked questions
Is the sponsor always the manufacturer?
No. Their roles may be performed by different businesses.
Who should a patient contact about a fault?
A healthcare professional or supplying pharmacy is a practical starting point; the official TGA incident-reporting route is also available.
Read more on this topic
- Medical Devices & TGA: topic overview
- Essential Principles for Medical Devices Explained
- Conformity Assessment: An Introductory Guide
Official sources
- TGA — Medical device inclusion process
- TGA — Quality, safety and performance: Essential Principles
- TGA — Medicinal cannabis vaping devices: importers, exporters and manufacturers (7 July 2026)
This educational information is not individual medical advice. It does not establish the regulatory status or suitability of an unidentified device, and must not be read as authorisation to advertise vaping goods to the Australian public.