Legal Radar

The Therapeutic Goods Administration (TGA) has fined a Western Australian dentist $5,328 for allegedly importing hyaluronic acid pre-filled syringes that were not approved for supply in Australia.

The dentist received two infringement notices after importing injectables that were not included on the Australian Register of Therapeutic Goods (ARTG).

Under the Therapeutic Goods Act 1989, all medical devices and medicines must be listed on the ARTG before they can be legally imported or supplied—unless a specific exemption or approval applies.

The syringes in question contained hyaluronic acid. While legal products containing hyaluronic acid are widely available in Australia, they must be registered and approved by the TGA to ensure their safety, quality, and efficacy.

Why It Matters

The TGA has expressed concern about a rise in the importation of unapproved therapeutic goods, especially cosmetic injectables. These products may bypass important safety checks and quality standards, putting both patients and practitioners at risk.

The regulator has made it clear that it will take a strong enforcement approach against unlawful importation and use of unapproved medical devices. This can include not only infringement notices but also court proceedings and significant penalties.

Key Takeaways

If your practice offers cosmetic injectables, it’s essential to:

• Check the ARTG before importing or supplying any product.
• Ensure you have the necessary approvals or exemptions if you’re using products not on the ARTG.
• Understand that non-compliance can result in fines, enforcement action, and reputational damage.