Therapeutic Goods (Overseas Regulators) Amendment Determination 2025

Overview

The Therapeutic Goods (Overseas Regulators) Amendment Determination 2025 was enacted to address gaps and update the definitions and list of recognised overseas regulators under the Therapeutic Goods Act 1989. This amendment was made by Tracey Duffy, as delegate of the Secretary of the Department of Health, Disability and Ageing, and it aims to align the definitions and scope of recognised overseas regulators with international standards and practices. The policy objective is to ensure that the therapeutic goods regulatory framework remains effective and consistent with international best practices, thereby facilitating trade and maintaining high standards of safety and efficacy for therapeutic goods in Australia. The determination amends the Therapeutic Goods (Overseas Regulators) Determination 2018 to update the definitions of key terms and to expand the list of recognised overseas regulators. These changes are intended to reflect the evolving landscape of global regulatory practices and to ensure that Australia’s regulatory framework for therapeutic goods is robust and adaptable to changes in international standards. The amendments aim to facilitate smoother regulatory processes for the import and export of therapeutic goods by recognising and incorporating international regulatory bodies and practices.

Scope and Application

The Therapeutic Goods (Overseas Regulators) Amendment Determination 2025I amends the Therapeutic Goods (Overseas Regulators) Determination 2018, which is governed under the Therapeutic Goods Act 1989. This determination applies to entities involved in the regulation and oversight of medical devices within the scope of therapeutic goods, specifically those recognised or authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council. This encompasses Australia’s Therapeutic Goods Administration, the United States Food and Drug Administration, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency. Additionally, it includes a UK approved body as defined by the Medical Devices Regulations 2002 in England, Wales, and Scotland. The amendment repeals and substitutes certain definitions and entities, ensuring clarity and alignment with current regulatory practices. The amendments took effect from 1 December 2025.

Key Provisions

The Therapeutic Goods (Overseas Regulators) Amendment Determination 2025 (the "Determination") amends the Therapeutic Goods (Overseas Regulators) Determination 2018 (the "2018 Determination"). The Determination, which comes into effect on 1 December 2025, is made under subsection 41BIB(2) of the Therapeutic Goods Act 1989 (the "Act"). The main changes include the repeal and substitution of definitions in the 2018 Determination and the addition of new entities to be recognised as overseas regulators for the purposes of the Act. The Determination makes several amendments to the definitions set out in the 2018 Determination. For instance, it repeals the note and definition of "recognised auditing organisation" in Section 4 of the 2018 Determination, substituting them with new definitions that refer to an organisation recognised or authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council (the "Council"). The Council comprises Australia's Therapeutic Goods Administration, the United States Food and Drug Administration, Brazil's Agência Nacional de Vigilância Sanitária, Health Canada, Japan's Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency. Additionally, the Determination includes a new definition of "UK approved body" and "UK Regulations," referencing the Medical Devices Regulations 2002 (SI 2002/618), as in force in England, Wales, and Scotland on 1 December 2025. The Determination also modifies Section 5 of the 2018 Determination, repealing the previous list of overseas regulators and substituting it with a new list. This includes IAF accredited conformity assessment bodies, notified bodies, recognised or authorised auditing organisations, Health Canada, Health Sciences Authority of Singapore, Japan's Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, the United States Food and Drug Administration, and UK approved bodies. The Determination imposes obligations on entities to comply with the new definitions and the list of overseas regulators. For example, entities must ensure that any audits performed by recognised or authorised auditing organisations are conducted in accordance with the standards set by the Council. Furthermore, entities must ensure that any conformity assessment bodies or notified bodies they engage with are accredited by IAF or recognised by the appropriate regulatory authority. Failure to comply with these obligations may have legal consequences under the Act. Under the Act, there are potential civil and criminal penalties for non-compliance with the requirements set out in the Determination. For example, contravening the provisions of the Act may result in civil penalties, including fines of up to $1.1 million for corporations and $220,000 for individuals. In addition, individuals who intentionally or recklessly contravene the Act may face criminal penalties, including fines of up to $660,000 and/or imprisonment for up to five years. It is important for entities to ensure that they comply with the Determination to avoid any potential legal consequences.