Australian TGA Updates Regulatory Status of Borderline Products with Amending Legislation

By Evan Ruby and Lori White

Background

The medical device regulator in Australia, the Therapeutic Goods Administration (TGA), utilizes legislation (Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020) to specify certain “boundary products” as medical devices under the Therapeutic Goods Act 1989. Similarly, legislation is promulgated for products that are not medical devices. 

New medical device products

The Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025, effective January 1, 2026, adds seven product types to the list of specified medical devices, as follows:

• Locking solutions to be used in vascular access devices that are intended to be used solely to maintain the patency of the device.
• Substances generated by ozone generators, which are intended to be used for: (a) sanitizing or disinfecting a medical device or medical equipment, or (b) cleaning of the oral cavity.
• Pre-filled saline flush syringes where the saline is only intended to maintain the patency or to flush the lumen of a medical device.
• Weight loss treatments that are ingested into the body and that achieve their principal intended action only through physical means, e.g., capsules that expand in the stomach to create a feeling of satiety.
• Head or body lice treatments that achieve their principal intended action only by means of physical action, e.g., products that coat the hair shaft to prevent lice/egg attachment.
• Toothpastes and other dentifrices that achieve their principal intended action only by means of physical action, e.g., products that block the dental tubules to reduce/treat sensitivity.
• Moisturizers and emollients that achieve their principal intended action only by means of physical action, e.g., products that act as a barrier.

New products that are not medical devices

Conversely, the Therapeutic Goods (Articles that are Not Medical Devices (Amendment Declaration (No. 2) 2025, also effective January 1, 2026, specifies four classes of boundary products that are not considered medical devices when their principal intended action is achieved through means other than physical (e.g., chemical, pharmacological, or metabolic), including toothpastes and other dentifrices, head or body lice treatments, moisturizers and emollients, and weight-loss treatments affecting calorie absorption.

Regulatory status based on primary mode of action

These determinations accentuate that the means by which a product achieves its principal intended action is central to its regulatory classification. For instance, head or body lice treatments are considered medical devices when their primary mode of action is purely physical; if the principal intended action is achieved through chemical or pharmacological means, they fall outside the medical device framework. Similar considerations apply to toothpastes and other dentifrices, moisturizers, and weight-loss aids. 

Concluding remarks and transitional provisions

To support stakeholders in interpreting these distinctions, the TGA has updated its guidance, “Understanding Rules for Boundary and Combination Products,” to reflect these updated determinations. 

These legislative instruments are both effective January 1, though they introduce five-year transitional provisions for manufacturers of affected products to implement the necessary adjustments and comply with the applicable regulatory requirements. By January 1, 2031, specified articles not already listed in the Australian Register of Therapeutic Goods (ARTG) must be included there (and compliant with the medical device legislation), and ARTG listings for the boundary products deemed to not be medical devices must be cancelled.