Related Instruments & Determinations
Overview
In addition to the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, a number of related legislative instruments and determinations apply to medical devices in Australia. These are made under the authority of the Act by the Minister or Secretary of the Department and have legal force. They are updated more frequently than the Act or Regulations and cover specific topics such as device nomenclature, specified articles, exemptions, and standards.
Therapeutic Goods Regulations 1990
The Therapeutic Goods Regulations 1990 (TG Regulations) apply to all therapeutic goods — not just medical devices. Key provisions relevant to medical devices include:
- Schedule 2 — Prohibited and restricted representations in advertising (applies to all therapeutic goods including devices)
- Provisions relating to manufacturing licences (where relevant)
- Fees and charges supplementary to those in the MD Regulations
👉 Therapeutic Goods Regulations 1990 — Current text
Therapeutic Goods (Charges) Act 1989
The Therapeutic Goods (Charges) Act 1989 is the primary legislation imposing annual charges on ARTG entries. It operates alongside the fees provisions in the MD Regulations (Schedule 5) and the TG Regulations.
👉 Therapeutic Goods (Charges) Act 1989
Specified Articles Instrument
Therapeutic Goods (Medical Devices — Specified Articles) Instrument 2020 This instrument specifies additional articles that are taken to be medical devices for the purposes of the Act, beyond those that meet the primary definition in s41BD. Updated periodically as new device types are identified for regulation.
👉 Specified Articles Instrument 2020 — legislation.gov.au
Standards Orders
The TGA can make Therapeutic Goods Orders (TGOs) that set mandatory standards for therapeutic goods. Standards orders relevant to medical devices include requirements for labelling, sterilisation, and specific device types. Compliance with a relevant TGO is mandatory — it is not optional in the way that compliance with a guidance document is.
Key standards orders to be aware of (check TGA website for current list):
- TGO 93 — Standards for medical devices (labelling)
- Sterilisation and packaging standards orders (check current status)
👉 Therapeutic Goods Orders — TGA
Device Nomenclature Determination
The Minister has power under s41BHA of the Act to determine device nomenclature codes for medical devices. Sponsors are required to use approved nomenclature codes (such as GMDN codes — Global Medical Device Nomenclature) when applying for ARTG inclusion. The GMDN code helps the TGA identify and categorise the type of device being included.
👉 GMDN codes — Global Medical Device Nomenclature Agency
Advertising Code
Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 A legislative instrument setting advertising standards for all therapeutic goods including medical devices. Compliance with the Code is mandatory — breaches are criminal offences.
👉 Advertising Code 2021 👉 Advertising Rules
Special Access Scheme Rules
Therapeutic Goods (Medical Devices — Authorised Supply) Rules 2022 Rules authorising certain health practitioners to supply specified kinds of medical devices (under the SAS Category C pathway) without ARTG inclusion. Updated periodically as new device types are added or removed from the authorised supply list.
UDI Instruments
Legislative instruments have been made progressively implementing Unique Device Identification (UDI) requirements for medical devices. These instruments specify which device classes must comply with UDI labelling requirements and by when.
Finding Current Instruments
The Federal Register of Legislation (legislation.gov.au) is the authoritative source for all current Commonwealth legislation and legislative instruments. Search for "Therapeutic Goods" to find all current instruments.
👉 Federal Register of Legislation
The TGA also maintains a legislation index on its website: