Skip to main content

Who Needs to Comply?

Overview​

Australian medical device regulation places obligations on different parties depending on their role in the supply chain. The two primary roles are manufacturer and sponsor — and they carry distinct, non-overlapping legal responsibilities. Getting clarity on which role applies to you (or your client) is the essential first step before any compliance work begins. The same person or organisation can hold both roles simultaneously, which is common for Australian manufacturers supplying their own devices domestically.

The Two Primary Roles​

Manufacturer​

A manufacturer is the person or organisation that is responsible for the design, production, fabrication, assembly, or labelling of a medical device, with the intention of supplying it under their own name or trademark. The manufacturer is responsible for the device itself — its design, evidence of safety and performance, conformity assessment, and technical documentation.

Key manufacturer obligations include:

  • Designing the device to meet the Essential Principles
  • Applying appropriate conformity assessment procedures
  • Holding and maintaining technical documentation
  • Monitoring the device's performance post-market
  • Reporting adverse events (through the sponsor)

👉 Detailed page: Manufacturers

A sponsor is the Australian-based legal entity responsible for the import into, export from, or supply of a medical device within Australia. Every device supplied in Australia must have an Australian sponsor. For overseas manufacturers, the sponsor acts as the point of contact between the manufacturer and the TGA.

Key sponsor obligations include:

  • Applying to include the device in the ARTG
  • Ensuring the manufacturer's evidence is current and valid
  • Reporting adverse events to the TGA
  • Managing recalls and field safety corrective actions
  • Maintaining distribution records

👉 Detailed page: Sponsors

Other Roles​

Importers​

In many supply chains, an importer brings goods into Australia but is not the sponsor. However, if you import a medical device for supply in Australia and you are the first point of supply, you are likely the sponsor — not merely an importer. The distinction matters because sponsor obligations are significantly more extensive than those of a downstream distributor. If you import a device that already has an ARTG entry held by someone else, you are generally a distributor rather than a sponsor.

👉 Detailed page: Importers

Consultants and Regulatory Affairs Professionals​

Regulatory consultants and RA professionals assist manufacturers and sponsors to understand and meet their obligations. They do not themselves hold regulatory responsibility — that remains with the manufacturer and sponsor. However, their advice directly shapes whether their clients comply with the law. This site is designed with RA professionals as a primary audience: a reliable, well-structured reference for the regulatory requirements you navigate daily.

👉 Detailed page: Consultants & Auditors

Health Professionals​

A health professional who imports a medical device for use in their clinical practice — including purchasing directly from an overseas supplier — can become the sponsor of that device under Australian law, with all associated obligations. This is a common source of inadvertent non-compliance. If a health professional is supplying a device to the Australian market, including by administering it to patients, they may also be the sponsor.

Authorised Representatives​

An overseas manufacturer can appoint an Australian entity to act as their authorised representative and sponsor. This is often a regulatory consulting firm, a distributor, or a dedicated regulatory affairs company. The authorised representative takes on sponsor obligations in Australia on behalf of the overseas manufacturer.

What Happens if You Get It Wrong​

Non-compliance with Australian therapeutic goods legislation carries serious consequences:

  • Civil penalties (infringement notices)
  • Criminal prosecution — up to 5 years imprisonment and/or 5,000 penalty units for serious offences such as supplying devices not included in the ARTG
  • ARTG cancellation or suspension
  • Mandatory recalls
  • Publication of non-compliance on TGA's website

The penalties apply equally to manufacturers, sponsors, and importers depending on which obligations were breached.

Official Sources​