TGA Compliance Principles 2026–2027: What the Update Means for Industry
Recent Regulatory Update
In January 2026, the Therapeutic Goods Administration (TGA) released its Compliance Principles for 2026–2027, outlining how the regulator intends to monitor and enforce compliance across the therapeutic goods sector over the next two years.
The updated framework reflects a refreshed approach to compliance oversight, replacing the previous 2023–2025 compliance priorities with a broader strategic model based on five core principles.
These principles will guide enforcement activities relating to the import, export, manufacture, supply, and advertising of therapeutic goods in Australia, including medical devices.
The five principles are:
- Safeguarding therapeutic goods
- Educate to empower
- Protect those most at risk
- Leverage digital capability
- Strengthen enforcement
Importantly, the TGA has indicated that priority focus areas will now be reviewed quarterly, allowing the TGA to respond more quickly to emerging risks and compliance issues.
Why This Update Matters
The move from fixed compliance priorities to guiding principles signals a shift toward more agile and intelligence-led regulatory oversight.
Rather than focusing only on specific product categories, the new framework allows the TGA to:
- respond more rapidly to emerging public health risks
- monitor online advertising and digital marketplaces more actively
- address misinformation and misleading promotional claims, particularly through social media and influencers
- strengthen enforcement actions where significant non-compliance is identified.
For manufacturers and sponsors, this reinforces the expectation that compliance is ongoing and proactive, rather than limited to pre-market approval or certification.
Emerging Compliance Focus Areas
Although the framework is principle-based, the TGA has indicated that some current areas of focus (applying to Medical Devices and IVDs) include:
- Direct to consumer in vitro diagnostic (IVD) kits
- Foetal Dopplers
- Digital advertising and social media promotion of therapeutic goods
- Supply of unapproved or falsified products, including those sold through e-commerce platforms
- Products promoted through misleading endorsements or influencer marketing
- Technologies such as Software as a Medical Device (SaMD)
The TGA is also increasing its ability to monitor online environments and detect non-compliant marketing activity using digital surveillance tools.
Evergreen Compliance Expectations
While the 2026-2027 Compliance Principles outline how the TGA will approach enforcement, the underlying regulatory obligations remain unchanged.
For sponsors and manufacturers, key compliance responsibilities continue to include:
- Post-Market Obligation: Maintaining systems to monitor device performance once products are supplied in Australia, including complaint investigation, adverse event reporting and taking timely market action when required i.e. recall.
- Advertising Compliance: Ensuring marketing materials remain consistent with the device’s approved intended purpose and comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.
- Quality Management Systems: Maintaining effective quality management systems to manage risk, change control, supplier oversight, and corrective actions.
Takeaway for Sponsors and Manufacturers
The 2026-2027 Compliance Principles reinforce a broader regulatory trend: global regulators, including the TGA, are increasingly using risk-based, intelligence-led oversight combined with proactive digital monitoring.
For industry, this means compliance should be treated as an ongoing lifecycle responsibility, supported by robust governance, quality systems, and careful oversight of marketing and supply practices.
If you would like assistance reviewing your regulatory compliance strategy or post-market obligations, please contact the KD&A team.
