What has changed
The federal government registered the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 on 7 September 2026. The regulations make amendments to two existing instruments: the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990.
Commencement dates
The amendments come into effect in stages:
- The day after registration - some amendments commenced the day after registration.
- 28 days after registration - a further set of amendments commences 28 days after registration.
- 1 November 2026 - an additional set of amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 commences on this date.
Defence exemptions
The regulations include specific changes covering exemptions for Defence use of therapeutic goods and medical devices.
Scope of the amendments
The source does not specify which products, businesses, or device categories are affected by each part of the amendments.
Key actions
- Businesses that supply, import, or manufacture therapeutic goods or medical devices can check the full text of the regulations at https://www.legislation.gov.au/F2026L01167 to identify which amendments apply to their products.
- A further set of Therapeutic Goods (Medical Devices) Regulations 2002 changes commences 1 November 2026 - the full regulation text is available to review compliance processes before that date.
- The Department of Health, Disability and Ageing can be contacted directly for clarification on how these amendments affect specific products or registration obligations.
This is a plain-English summary for information only, not legal or compliance advice. Always check the official source or consult a qualified professional.