In this article
Identify what you are looking atSeparate the different identifiersWarnings and special symbolsWhen the label raises a questionExample: putting the information in contextWhat to check nextFrequently asked questionsMust every device have the same labels?Is a CE symbol proof of Australian ARTG inclusion?Read more on this topicOfficial sourcesRelated articles
Medical-device labels contain identification and use information that helps connect the item in someone’s hands to its documentation and, where applicable, an Australian regulatory record.
Identify what you are looking at
Relevant information may appear on the device, primary package or accompanying documentation. Examples include manufacturer identification, model or product reference, lot or serial details, warnings and conditions of storage or use.
Separate the different identifiers
A brand is not a model number; a serial number is not an ARTG number. UDI information is another identification system that is being introduced progressively to specified device classes in Australia. Do not infer regulatory approval from a barcode alone.
Warnings and special symbols
Labels can signal cautions about heat, electrical requirements, batteries, single-use components or environmental conditions. Symbols need to be interpreted together with the instructions for use, rather than guessed from appearance.
When the label raises a question
Compare the label with the current IFU and official ARTG search details. Preserve packaging if you need to investigate a product fault or recall. If the identification is absent or inconsistent, ask the supplier or sponsor before relying on that item.
Example: putting the information in context
A product box has a long alphanumeric code near a barcode. It may be a stock code, batch number or UDI component; it should not be read as an ARTG inclusion without official confirmation.
What to check next
- Compare the name and model on the label and the IFU.
- Record applicable lot, serial and UDI identifiers accurately.
- Verify supply status through ARTG rather than assuming a barcode proves it.
Frequently asked questions
Must every device have the same labels?
No. Requirements depend on the device, class, circumstances and applicable transitional rules.
Is a CE symbol proof of Australian ARTG inclusion?
No. Australian supply status must be checked separately.
Read more on this topic
- Medical Devices & TGA: topic overview
- What Is a Medical Device Adverse Event?
- Medical Device Recalls and Safety Alerts in Australia
Official sources
- TGA — Unique Device Identification implementation in Australia
- TGA — Searching the Australian Register of Therapeutic Goods
- TGA — Quality, safety and performance: Essential Principles
This educational information is not individual medical advice. It does not establish the regulatory status or suitability of an unidentified device, and must not be read as authorisation to advertise vaping goods to the Australian public.