The Current Situation Of Pharmaceutical-grade Regulation For Electronic Cigarettes: Can The Australian Market Still Do It?

The Therapeutic Goods Administration (TGA) of Australia confirmed that the "Amendment to the Medicines and Other Legislation (E-cigarettes Reform) Bill 2024" has been fully implemented as of July 1, 2025. At that time, all e-cigarette products sold in Australia must simultaneously meet the "pharmaceutical grade" requirements of the Therapeutic Goods Ordinance (TGO 110) and the Medical Device Regulation (MDSO 2024). Those that fail to meet the standards will be prohibited from import, distribution, or retail.
Timeline Tightening
From October 1, 2024, only e-cigarettes that comply with the new regulations can be legally supplied;
From March 1, 2025, production factories must hold ISO 13485 certification (the current ISO 9001 will be abolished);
From July 1, 2025, any non-compliant products will be removed from the shelves.
Dual Standards Set Safety Boundaries
TGO 110:
Imposes strict regulations on the vaporizing substances: nicotine concentration ≤ 50 mg/ml;
The flavors are limited to four types: original flavor, mint, menthol, and tobacco;
Each bottle of e-liquid should be ≤ 60 mL, each cartridge ≤ 5 mL, and must pass the child protection test (ISO 8317/AS 19288).
MDSO 2024:
Includes the entire e-cigarette as a medical device, requiring manufacturers to have the ISO 13485 quality management system and meet safety standards such as IEC 62133 in aspects such as battery explosion prevention, overheating prevention, and tamper-proofing. The appearance color is limited to white, gray, or black, and the outer packaging must have mandatory warning statements such as "KEEP OUT OF REACH OF CHILDREN".
Only Two Paths for Legal Sales
The TGA stated that enterprises can choose:
1. List the products in the Australian Therapeutic Goods Register (ARTG), but currently no e-cigarettes have passed this path;
2. Submit a pre-market notification to the TGA and enter the import whitelist, which is the mainstream solution at present.
Black Market Impact and Enforcement Intensification
The New South Wales Department of Health announced yesterday that illegal sales of e-cigarettes can result in a maximum sentence of 7 years in prison and a fine of 1 million Australian dollars; illegal stores can be forcibly closed for 90 days to 12 months. However, Victoria only has 14 full-time inspectors, and industry insiders are concerned that insufficient enforcement resources may lead to the continued proliferation of the black market.
Industry Urgent Response

The Australian E-cigarettes Association disclosed that more than 30 brand owners have initiated factory relocation and formula adjustments, aiming for ISO 13485 certification and submitting TGA notifications. Any delay is equivalent to automatically giving up the Australian market."