Australia, 16 December 2025 — The Therapeutic Goods Administration (TGA) has formally published updated guidance and legislative instruments regarding the regulation of “Boundary and Combination Products“. These changes, finalized in the Therapeutic Goods (Medical Devices Specified Articles) Amendment Instrument 2025, represent a significant shift in how the TGA classifies products that sit on the border between medicines and medical devices. For years, manufacturers of products like medicated moisturizers, saline syringes, and weight loss capsules have navigated a complex regulatory “grey area.”
The new framework resolves this ambiguity by strictly enforcing classification based on the product’s Principal Mode of Action. The TGA is moving away from regulating based solely on marketing claims and is instead focusing on the mechanism of how the product achieves its intended purpose.
- Medical Device Pathway: Applies if the product acts primarily by physical means (e.g., creating a barrier, occupying space, flushing, or blocking pores).
 - Medicine Pathway: Applies if the product acts primarily by pharmacological, chemical, or metabolic means (e.g., suppressing immune responses, altering metabolism, or chemically poisoning parasites).
TIMELINE FOR MANUFACTURERS: WHAT TO EXPECT WITH THE TGA 2025 CHANGES
The publication of this instrument triggers a two-phase compliance timeline designed to allow manufacturers to adjust their regulatory strategies without immediate market disruption.
- From 1 January 2026 (The “Hard” Start): The new rules formally come into force. Any new product inclusions submitted to the Australian Register of Therapeutic Goods (ARTG) after this date must be entered under the correct regulatory pathway at the time of inclusion. For example, a new barrier cream application must be submitted as a medical device, not a listed medicine.
- By 31 December 2030 (The Transition Deadline): The transition period ends. Products that are currently listed in the ARTG under an “incorrect” pathway (e.g., a saline flush currently listed as a medicine) have a five-year grace period to transition to the correct pathway. Manufacturers must use this window to re-register their products. If a product is not aligned with the new classification by this date, it will be considered non-compliant and may be removed from the market.
THE IMPACT OF THE 2025 TGA MEDICAL DEVICE CLASSIFICATION UPDATE
The guidance provides a definitive reclassification for several high-volume product categories. Manufacturers of the following goods should conduct an immediate gap analysis.
Skincare, Emollients & Moisturizers
The distinction here relies entirely on the mechanism of action.
- Medical Device: Products where the principal intended action is achieved by physical means, such as creating a protective barrier to retain moisture or protect skin from the external environment.
Example: A petroleum jelly-based moisturizer that treats eczema by physically trapping moisture. - Medicine: Products containing therapeutically active ingredients where the principal action is pharmacological, chemical, or metabolic.
Example: A moisturizer that claims to reduce disease symptoms by chemically suppressing the immune response.
Weight Loss Treatments
- Medical Device: Ingested capsules or products that expand in the stomach to create a feeling of satiety (fullness) by simply occupying space and are not absorbed by the body.
- Medicine: Weight loss treatments that affect the absorption of food or alter metabolism in the gastrointestinal system.
Head Lice Products
- Medical Device: Treatments that eliminate lice through physical means, such as combs, lubricants that suffocate the lice, or devices that electrocute them.
- Medicine: Treatments that achieve their effect through chemical or pharmacological means, such as shampoos causing neurotoxicity to the lice.
Vascular Access & Saline Products
- Medical Device: Pre-filled saline flush syringes and vascular access device locking solutions are now clearly devices if their primary purpose is physical flushing or maintaining patency.
- Key Note: These products remain classified as medical devices even if they contain “ancillary” therapeutically active ingredients, such as antibiotics or anticoagulants (e.g., Heparin), provided the primary action remains physical.
Ozone Generators
- Medical Device: Generators used specifically for sanitizing other medical devices or for cleaning the oral cavity.
- Excluded/Other: Generators producing ozone for general household or hospital-grade surface disinfection (without specific medical claims) remain regulated as “Other Therapeutic Goods” or are exempt.
Oral Hygiene
- Medical Device: Toothpastes that work by physically blocking dentine pores to reduce sensitivity.
- Medicine: Toothpastes containing ingredients like potassium nitrate that chemically block pain signals to the nerve.
Strategic Implications
For manufacturers, reclassification is not merely an administrative update. Moving a product from a “Medicine” listing to a “Medical Device” inclusion involves fundamentally different compliance requirements.
- Evidence Requirements: Medical devices require clinical evidence supporting the physical mode of action and performance, which differs from the efficacy data required for medicines.
- Quality Systems: Manufacturers transitioning to the device pathway must ensure their Quality Management Systems (QMS) align with medical device standards (e.g., ISO 13485) rather than GMP for medicines.
- Conformity Assessment: Higher-risk devices may now require third-party conformity assessment certification, a process that can take significant time.
RESOURCES
- Guidance Document: Understanding rules for boundary and combination products
- Legislation: Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025