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Labelling Requirements

Overview​

Medical device labelling requirements in Australia are primarily set out in Essential Principle 13 (Schedule 1 of the MD Regulations), with supplementary requirements in the Therapeutic Goods Act 1989 and various TGA guidance documents. Labelling includes everything that accompanies the device — the label on the device and its packaging, instructions for use (IFU), patient information leaflets, patient implant cards, and electronic information for software devices. The manufacturer is responsible for labelling design and content; the sponsor is responsible for ensuring labelling meets Australian requirements before supply.

Mandatory Label Elements — EP 13​

Under EP 13, medical device labels and packaging must include the following information (where applicable to the device):

On the device or primary packaging label:

  • Manufacturer's name and address — clearly identified as the manufacturer
  • Device name or trade name — sufficient to identify the device
  • Batch or lot number, or serial number — for traceability
  • Expiry date (if applicable)
  • Storage and handling conditions — if special conditions are required
  • Sterility indicator — if the device is supplied sterile (use of ISO 15223 symbols is accepted)
  • Single-use symbol — if the device is intended for single use (do not use symbol)
  • Warnings and precautions — any information essential to safe use
  • Intended purpose — sufficient to allow the user to understand the intended use (may be on IFU rather than label in some cases)
  • ARTG number — the Australian ARTG entry number must be displayed on or with the device

For sterile devices:

  • The word "STERILE" or equivalent ISO 15223 symbol
  • Method of sterilisation (where relevant)
  • Do not use if packaging damaged indicator

For devices with a measuring function:

  • Measurement units in Australian legal units of measurement

Instructions for Use (IFU)​

Every device must be supplied with adequate instructions for use unless the device is simple enough that the label alone is sufficient. The IFU must include, as applicable:

  • Intended purpose and indications for use
  • Contraindications and warnings
  • Instructions for installation, operation, use, and maintenance
  • Information about residual risks, side effects, and precautions
  • Information about reprocessing (for reusable devices)
  • Shelf life and storage conditions
  • Any limitations of the device

For software: IFU may be provided electronically (on screen or in a downloadable file). For hardware devices, the IFU must be provided on a physical leaflet (or electronically where permitted).

EP 13B — Software Version Numbers​

Under EP 13B (added 2021), software-based medical devices must display the current version and build number of the software in a way that is identifiable and accessible to users. The version and build number must be presented in English.

Patient Implant Cards​

From 1 November 2024, manufacturers and sponsors of implantable medical devices must provide patient implant cards. Patient implant cards are given to patients at the time of implantation and contain:

  • Device identification information
  • Manufacturer details
  • ARTG number
  • UDI (where applicable)
  • Any warnings relevant to the patient's ongoing management

👉 Patient implant card requirements — TGA

UDI Labelling Requirements​

The TGA is progressively implementing Unique Device Identification (UDI) requirements for medical devices. UDI must be included on device labels in machine-readable format (barcode or QR code) and as human-readable text. UDI requirements are being phased in by device class, with higher-risk classes required to comply first.

👉 UDI labelling — TGA

Language Requirements​

Labels and IFUs for devices supplied in Australia must be in English. Where labelling is in multiple languages, English must be clearly included. Symbols complying with ISO 15223 may be used in place of text for standard symbols (sterility, single-use, batch number, etc.).

Off-Label Use​

A device may not be supplied or advertised for uses outside its ARTG-approved intended purpose without appropriate approvals. Where a health professional uses a device off-label (outside its approved intended purpose), the manufacturer and sponsor are not responsible for that use — but they must not promote or facilitate off-label use in their labelling or advertising.

Official Sources​