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The TGA is currently investigating the CHOICE report on Sunscreen SPF testing, as per our previous statement on 21 August 2025. This update outlines the steps that sunscreen sponsors should take if they identify a problem with their product.

We have published a list of medical devices in the ARTG that incorporate artificial intelligence (AI) or machine learning (ML) technologies.

Know how we manage compliance of AI and software products that meet the definition of a medical device.

Information for health professionals about medicines with safety related updates to their Product Information.

We are currently investigating the CHOICE report on sunscreen SPF, as per our previous statement on 19 June 2025. This update recognises the significant public interest in this matter.

The GMP Clearance SID now contains additional data as well as progress information on the Compliance Verification (CV) backlog reduction strategy.

We have published information to clarify when digital scribes - also referred to as AI scribes or ambient scribes - are regulated as medical devices in Australia.

There has been an increase in the illegal advertising and online sales of nicotine pouches, with many of these products being imported from overseas.

The TGA is updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI).

We have published our Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) report.

Information for health professionals about medicines with safety related updates to their Product Information.

The TGA has facilitated the seizure of millions of counterfeit and illegal therapeutic goods as part of a global initiative targeting illegal trade.

Information on the completion of automatic extensions for Good Manufacturing Practice (GMP) clearances and next steps.

Following a number of stakeholder queries, the TGA is providing an updated statement on the PFAS ban. The original statement was published on 27 June 2025.

An update about expected increases in the number of medical device incident reports reported to the TGA

Temporary risk-based strategies to expedite the reduction of the GMP Clearance Compliance Verification (CV) backlog commences today.

Australians who rely on medical devices will benefit from new measures introduced by the Australian Government to enhance the identification and management of device-related safety concerns.

Medical devices, including components in the device, primary packaging, instructions for use, and spare parts, will not be affected by the PFAS ban.

Information for health professionals about medicines with safety related updates to their Product Information.

Information about the indications for the individual products and how to avoid administration errors.

This statement is an update to provide technical clarification regarding information on laboratory testing and release of information by the TGA. The original statement was published on 12 June 2025.

We are aware of a CHOICE report where a number of sunscreens were found to not meet their claimed Sun Protection Factor (SPF) ratings.

New warnings added of risks during anaesthesia or deep sedation.

The Therapeutic Goods Administration has commenced proceedings in the Federal Court of Australia against Philips Electronics Australia Limited (PEAL) for the alleged unlawful supply of medical devices that did not meet Australian safety and performance requirements.

Temporary risk-based strategies are being introduced to expedite the reduction of the Good Manufacturing Practice (GMP) Clearance Compliance Verification (CV) backlog.