Skip to main content

Manufacturers

Overview​

The manufacturer of a medical device is the party ultimately responsible for its safety and performance. Under Australian law, the manufacturer is defined in Section 41BG of the Therapeutic Goods Act 1989 as the person who designs, produces, fabricates, assembles, or processes a finished medical device — and who takes responsibility for it by placing it on the market under their own name. This responsibility does not end at the point of sale. Manufacturers have ongoing legal obligations for as long as their device is supplied in Australia.

Who is the Manufacturer?​

The manufacturer is the entity that:

  • Takes overall responsibility for the design and production of the device
  • Places the device on the market under their own name, brand, or trademark
  • Determines the intended purpose of the device

Importantly, if a company rebrands or relabels a device manufactured by someone else and supplies it under their own name, that company becomes the manufacturer for regulatory purposes — even if they did not physically make the device. This is a common issue with private-label and OEM arrangements and carries significant regulatory implications.

If you are an Australian manufacturer, you are also automatically a sponsor for devices you supply domestically. Both sets of obligations apply.

Core Manufacturer Obligations​

1. Meet the Essential Principles​

The Essential Principles (Schedule 1 of the MD Regulations) are the fundamental safety and performance requirements all medical devices must meet. Manufacturers are responsible for demonstrating compliance through appropriate evidence — there is no single mandated format, but most manufacturers use a technical file or design dossier.

👉 Essential Principles overview

2. Apply Conformity Assessment Procedures​

Manufacturers must apply the conformity assessment procedures appropriate to the class of their device. These procedures are set out in Schedule 3 of the MD Regulations and require, depending on device class:

  • A quality management system certified by an appropriate body (ISO 13485 or equivalent)
  • A Declaration of Conformity
  • For higher-risk devices: a TGA-issued Conformity Assessment Certificate or equivalent overseas certification

👉 Conformity Assessment overview

3. Maintain Technical Documentation​

Manufacturers must hold comprehensive technical documentation that demonstrates compliance with the Essential Principles before the device is supplied in Australia. This documentation must be accessible to the Australian sponsor, who must be able to provide it to the TGA within specific timeframes when requested. Records must generally be kept for a minimum of 5 years after the last device is manufactured (or 15 years for Class III, AIMD, and implantable Class IIb devices).

4. Have a Written Agreement with Your Australian Sponsor​

Overseas manufacturers must have a written agreement with their Australian sponsor that addresses the exchange of regulatory information, including how adverse events and TGA requests will be handled. The TGA does not prescribe the format of this agreement but does specify minimum requirements for what it must cover.

5. Post-Market Monitoring​

Manufacturers are required to monitor the ongoing performance and safety of their devices in the market. This includes:

  • Reviewing adverse event reports and customer complaints
  • Investigating safety signals and taking corrective action
  • Keeping post-market surveillance records
  • Updating technical documentation when changes occur

6. Notify of Significant Changes​

Changes to a device's design, intended purpose, manufacturing process, or labelling may require notification to the TGA or a new ARTG application. Manufacturers must assess whether any change is a significant change under the Regulations and ensure their sponsor is notified so the ARTG entry can be updated if required.

Overseas Manufacturers​

If you are an overseas manufacturer supplying devices in Australia, you must:

  • Appoint an Australian sponsor who will manage the ARTG application and hold regulatory responsibility in Australia
  • Enter into a written agreement with your sponsor
  • Ensure your conformity assessment evidence is accepted by the TGA before supply commences
  • Provide your sponsor with technical information when requested, within the required timeframes

You can supply devices to multiple Australian sponsors, but each sponsor must have their own ARTG entry. You cannot share an ARTG entry between sponsors.

Australian Manufacturers​

If you manufacture devices in Australia and supply them domestically, you are both the manufacturer and the sponsor. This means you hold all manufacturer obligations and all sponsor obligations simultaneously. Australian manufacturers must have their quality management system assessed by the TGA (rather than a third-party overseas body) for certain device classes — check the conformity assessment requirements for your specific device class.

Official Sources​