ARTG (Australian Register of Therapeutic Goods)

The Australian Register of Therapeutic Goods (ARTG) is the official database maintained by the Therapeutic Goods Administration (TGA), Australia's medical device regulator. Therapeutic goods supplied in Australia must be included in the ARTG unless they qualify for an exemption or fall under special access provisions. The ARTG is publicly accessible and provides detailed records for each product entry, including classification information, sponsor and manufacturer details, and regulatory status.

What is the purpose of the ARTG?

The ARTG is a critical instrument for regulating therapeutic goods in Australia. Its primary functions include:

• Pre-market control: Products are evaluated for quality, safety, and performance by TGA before being listed.

• Post-market surveillance: The TGA monitors listed products for safety concerns, adverse events, and non-compliance.

• Transparency: Public access to ARTG records supports informed decision-making by clinicians, consumers, and regulators.

• Regulatory enforcement: Products can be cancelled from the ARTG if safety issues arise or regulatory requirements are not met.

Who registers products in the ARTG?

Sponsors (defined as Australian-based manufacturers or authorized representatives of overseas manufacturers) are responsible for ensuring ARTG entries for their products are accurate and up to date.

What types of products are listed in the ARTG?

Products listed in the ARTG include:

• Prescription and over-the-counter medicines

• Medical devices and in vitro diagnostic (IVD) devices

• Vaccines and other biologicals

• Complementary medicines such as vitamins, minerals, and herbal supplements

• Sunscreens and other topical health products

What is the ARTG listing process?

For medical devices, the ARTG listing requirements depend on the device’s risk classification. The Sponsor must submit documentation about the device to TGA, including conformity assessment evidence, manufacturer details, and device description and pay applicable fees. On approval from TGA, devices can be listed in the ARTG. Sponsors must continue to meet post-market obligations, including annual charges and participation in the TGA’s vigilance system, to maintain their registrations.

What information is included in an ARTG entry?

Entries typically include product name, classification, sponsor and manufacturer details, ARTG start date, effective date of last change, and, if applicable, device formulation or composition.