Australian TGA Announces Compliance Principles, Priority Focus Areas for 2026 - 2027

By Amelia Boldrick and Lori White

The Australian Therapeutic Goods Administration (TGA) announced (January 22) the release of the TGA Compliance Principles 2026 – 2027, unveiling a realignment around core principles to monitor and enforce the regulatory compliance of therapeutic goods, which include medical devices, over the next two years. 

Background on TGA compliance priorities

In the 2023 – 2025 compliance priorities, the TGA focused primarily on the detection, deterrence, and disruption of the unlawful import, advertising and supply of specific categories of therapeutic goods. Those of potential interest to medical device manufacturers included unapproved and high-risk devices used in the beauty and wellness industries and devices advertised as alternative or traditional treatments. 

From priorities to principles

The TGA has reorganized its strategic focus for 2026 and 2027 around five guiding principles:

• Safeguarding Therapeutic Goods
• Educate to Empower
• Protect Those Most at Risk
• Leverage Digital Capability
• Strengthen Enforcement

Under these principles, the TGA will continue to prioritize advertising compliance and disrupt the supply of unapproved, falsified, or otherwise violative products. However, greater emphasis is placed on monitoring e-commerce sites and online environments where advertising and misinformation come increasingly via social media influencers and AI. 

Even with principles, there are priority focus areas

The realignment around core principles (versus planned actions for categories of violative therapeutic goods) is still accompanied by a list of priority focus areas. Manufacturers of direct-to-consumer (DTC) IVD kits, fetal dopplers, software as a medical device (SaMD), and devices used in cosmetic procedures marketed in Australia should understand that the TGA intends to closely monitor these products over the next two years. 

In our experience, sponsors of listings for these devices may be required to respond to a Post Market Review (PMR), a formal request under section 41JA of the Therapeutic Goods Act 1989, in which they must work with the manufacturer to demonstrate legislative compliance within a mandated timeframe (typically 20 business days). 

Areas of overlapping focus in Australia and Brazil

As we reported earlier this month, this follows the announcement of 2026 – 2027 regulatory priorities from fellow Medical Device Single Audit Program (MDSAP) Regulatory Authority Council member, Brazil’s National Health Surveillance Agency (ANVISA). Products used in cosmetic/aesthetic procedures overlap on the TGA and ANVISA agendas, and as products become more complicated, both regulators are focusing on the categorization and classification of borderline products. 

Concluding remarks

The 2026-2027 principles provide insight into the TGA’s priority focus areas. Manufacturers of Direct-to-consumer IVDs, fetal dopplers, SaMD, and devices in cosmetic procedures should review their device compliance as well as PMS systems for compliance to the Australian legislation. In addition, manufacturers of boundary products should be aware of legislative amendments to add or remove devices within the remit of the legislation.     

The TGA has always balanced regulatory reliance with a strong proactive market surveillance system. Choosing a strong Australian sponsor like Emergo by UL, can facilitate a manufacturer’s knowledge and understanding of regulatory requirements.