In-vitro diagnostic medical device classification + ARTG
IVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
Who must comply
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.
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 required
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.
Max 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.
Who must comply with this? The applicability test by industry, business structure and size.
Summary
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.
Enforced by
Source legislation
Industries
Topics
Related
- CWLTHConduct post-market surveillance of therapeutic goodsARTG-included goods must be monitored post-market for safety + performance.
- CWLTHMaintain controlled drugs register (Schedule 8 / 9)Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.
- CWLTHMaintain PBS approval + claim accurately for PBS-listed medicinesPharmacy approval-to-supply under s 90 National Health Act; PBS claiming subject to compliance review.
- CWLTHComply with the Therapeutic Goods Advertising CodeAdvertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.
Frequently asked questions
- Who must comply with In-vitro diagnostic medical device classification + ARTG?
- 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 In-vitro diagnostic medical device classification + ARTG?
- 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.
- When is In-vitro diagnostic medical device classification + ARTG 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.
- What is the maximum penalty for In-vitro diagnostic medical device classification + ARTG?
- 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.
- What evidence is required for In-vitro diagnostic medical device classification + ARTG?
- 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.
Source: https://www.tga.gov.au/products/medical-devices/vitro-diagnostic-devices/overview/vitro-diagnostic-ivd-medical-devices/ivd-sponsors-roadmap-market. Rules Mate is not a law firm. Always verify against the live regulator source before acting.