Who must comply with In-vitro diagnostic medical device classification + ARTG?

IVDs classified by risk (Class 1-4); ARTG inclusion required for supply.

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. The pathway depends on the manufacturer's classification of the IVD under the classification rules, which turn on the device's intended purpose. Manufacturers need conformity assessment evidence appropriate to the class; for Class 2 to 4 IVDs this can be a TGA conformity assessment certificate or evidence from a comparable overseas regulator. The Australian sponsor applies through TGA Business Services and certifies classification, compliance with the Essential Principles and the conformity assessment applied. Self-test, point-of-care, Class 3 and Class 4 IVDs face a mandatory application audit unless backed by comparable overseas regulator certification.

Applies when the business has industry: Medical devices & therapeutic goods.

How the regulator frames it: Australian sponsors who import, export, supply or manufacture IVD medical devices, and the manufacturers whose classification, Global Medical Device Nomenclature (GMDN) code and conformity assessment evidence support the ARTG entry.

What triggers it: 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.

Jurisdiction: Commonwealth law, so the test is the same in every state and territory.

Outcome across the 35 industries Rules Mate maps (1 of 35: yes; 34 of 35: no).

Structure does not change the answer in medical devices & therapeutic goods: for every structure the answer is "yes".

Size does not change the answer in medical devices & therapeutic goods: at every size band the answer is "yes".

Each line is one run of the Rules Mate applicability engine for a single business profile, with the reason the engine gives:

• Pty Ltd company in medical devices & therapeutic goods with 6–19 employees, turnover $1M–$3M: applies. Industry: Medical devices & therapeutic goods.
• Pty Ltd company in real estate agents with 6–19 employees, turnover $1M–$3M: does not apply. Requires industry: Medical devices & therapeutic goods.

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.

Frequency

Ongoing

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.

Status

Current

Priority

Critical

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.

Rules Mate has not yet classified the audit or assurance level for this obligation. Any audit, review or certification requirement is set by the regulator source listed below.

If this obligation applies to you, so does this one: the engine uses the same rule for each.

• Conduct post-market surveillance of therapeutic goods

Across the 1,890 business profiles Rules Mate evaluates, these obligations apply to most of the businesses this one applies to, and are far more common among them than among businesses generally:

• Comply with the Therapeutic Goods Advertising Code: applies to 100% of the same businesses (35.0× the overall rate)
• Therapeutic Goods Advertising Code: applies to 100% of the same businesses (35.0× the overall rate)
• Notify ACCC of a voluntary recall within 2 days: applies to 100% of the same businesses (8.8× the overall rate)

Rules Mate tracks 4 published obligations tagged "medicines", 4 of them rated critical. For a professional services Pty Ltd company with 6–19 employees operating in every state, 0 of those apply outright. This obligation is rated critical priority and carries criminal liability, and is an ongoing duty.

Regulated by Therapeutic Goods Administration.

TGA: Regulator of therapeutic goods — medicines, medical devices, biologicals, and blood products. Administers the Therapeutic Goods Act and ARTG.

• Therapeutic Goods Administration

Therapeutic Goods Act 1989: Federal Therapeutic Goods Administration regime.

• Therapeutic Goods Act 1989

Free tools that help with this obligation:

• Compliance calendar builder