Does In-vitro diagnostic medical device classification + ARTG apply to medical devices and therapeutic goods?

In-vitro diagnostic medical device classification + ARTG. In vitro diagnostic (IVD) medical devices are tests that examine specimens taken from the human body, such as pregnancy tests, rapid antigen tests and pathology tests. Unless exempt or excluded, an IVD must be included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally supplied.

Trigger: Importing, exporting, supplying or manufacturing an IVD medical device in Australia, unless the device is exempt, excluded or covered by an approval or authority under the Therapeutic Goods Act 1989.

Rules Mate runs its applicability engine across 9 business structures and 6 size bands for each of the 35 industries it maps. For 34 of those industries the answer for "In-vitro diagnostic medical device classification + ARTG" is no. Medical devices & therapeutic goods is one of the 1 where the answer is different: yes.

The deciding fact for medical devices and therapeutic goods: Industry: Medical devices & therapeutic goods.

About the industry: Suppliers of therapeutic goods listed on the ARTG.

Compare a professional services (general) business with 6–19 employees structured as a Pty Ltd company: the obligation does not apply (Requires industry: Medical devices & therapeutic goods).

Each cell is the engine's outcome for a business in medical devices & therapeutic goods with that structure and size, assuming it sells to consumers and small businesses and holds customer contact details. "Check" means the obligation turns on a fact the industry does not settle.

When due

Before first supply: ARTG inclusion must be in place. After inclusion: ongoing post-market obligations, including adverse event reporting, and Unique Device Identification requirements being phased in from 1 July 2026, starting with higher-risk devices.

Evidence to keep

Manufacturer's classification and GMDN code; manufacturer's evidence (QMS certificate) accepted by the TGA; declaration of conformity; technical file supporting the Essential Principles; ARTG inclusion certificate; adverse event and post-market records.

Maximum penalty

Importing, exporting, supplying or manufacturing a medical device not included in the ARTG is a criminal offence (Therapeutic Goods Act s 41MI) and a civil penalty provision (s 41MIB): up to 5,000 penalty units ($1.82M) for an individual and 50,000 penalty units ($18.2M) for a body corporate. The TGA has also accepted an enforceable undertaking (2San Pty Ltd, July 2024) from a business that imported and supplied medical devices not included in the ARTG.

Regulator

TGA

Jurisdiction

Commonwealth (national)

• Conduct post-market surveillance of therapeutic goods: Yes
• Comply with anti-dumping + countervailing duties: Only if
• Comply with self-assessed clearance + Integrated Cargo System (ICS): Only if
• Comply with the Therapeutic Goods Advertising Code: Yes
• Customs Act 1901 — import declarations + duties: Only if
• Notify ACCC of a voluntary recall within 2 days: Yes
• All 8 answers for medical devices & therapeutic goods