Australia TGA Guidance: UDI for Medical Devices and OTC Medicine Application Requirements

Australia’s Therapeutic Goods Administration (TGA) continues to strengthen regulatory clarity through updated guidance documents covering medical devices and over-the-counter (OTC) medicines.

Guidance: Complying with Unique Device Identification requirements for medical devices – TGA

The TGA’s guidance on Unique Device Identification (UDI) requirements outlines the regulatory framework for assigning and maintaining UDIs for medical devices supplied in Australia. The UDI system is designed to improve traceability, enhance post-market surveillance, and support patient safety by ensuring each device can be uniquely identified throughout its lifecycle.

The guidance explains the responsibilities of sponsors and manufacturers, including assigning UDIs in accordance with approved issuing agencies and ensuring accurate data submission to the Australian UDI database (AusUDID). It also describes compliance timelines, labelling expectations, and transitional arrangements.

By implementing UDI requirements, the TGA aims to strengthen recall efficiency, adverse event reporting, and supply chain transparency for medical devices.

Guidance: Understanding requirements for over-the-counter (OTC) new medicine N2 applications – TGA

The guidance on N2 applications provides clarity for sponsors seeking approval for certain new OTC medicines. N2 applications typically involve new active ingredients, new indications, or other significant changes requiring evaluation of safety, efficacy, and quality data.

This document outlines dossier expectations, evaluation pathways, and data requirements. It helps sponsors understand what supporting evidence must be submitted, including clinical justification, quality documentation, and labelling proposals.

The guidance also explains assessment considerations and regulatory timelines to support well-prepared submissions and efficient evaluation. By clarifying the evidentiary standards, the TGA ensures that OTC medicines entering the market meet appropriate safety, quality, and performance standards.

Guidance: Determining the application level for umbrella-branded over-the-counter (OTC) medicines – TGA

This guidance addresses regulatory considerations for umbrella-branded OTC medicines. Umbrella branding refers to the use of a common brand name across a range of related products, which may differ in active ingredients, indications, or formulations.

The document assists sponsors in determining the appropriate application level when submitting variations or new applications for products within an umbrella brand. It highlights the importance of avoiding consumer confusion, ensuring clear differentiation between products, and maintaining compliance with labelling and advertising requirements.

The guidance also outlines how branding strategies interact with regulatory classification and evaluation pathways. Sponsors are encouraged to assess whether changes within an umbrella brand require a higher level of regulatory scrutiny based on differences in risk profile or intended use.

Together, these guidance materials support sponsors and manufacturers in navigating regulatory pathways effectively, ensuring that both medical devices and OTC medicines supplied in Australia meet established safety, quality, and performance standards.

For more details on these guidance documents, please click the respective links above to access the full official TGA publications.