Labelling Requirements for Medical Devices in Australia – TGA Guidance

Legal Basis

Labelling must meet Essential Principle 13 (information supplied by the manufacturer) under the Therapeutic Goods (Medical Devices) Regulations. Labels must enable users to identify the device, understand its intended purpose, and use it safely and effectively.

General Requirements

• Language: English is mandatory; additional languages permitted.
• Legibility: Clear, indelible, and easily readable under normal use conditions.
• Durability: Labels must remain attached and legible throughout the device's intended life.
• Format: Information may be on the device, packaging, or accompanying materials (e.g., IFU).

Minimum Information Required

• Device identifier: Name/trade name and unique identifier (e.g., catalogue number, lot/serial/batch).
• Manufacturer/sponsor details: Name and address of manufacturer and Australian sponsor (if applicable).
• Intended purpose: Clear statement of what the device is for.
• Instructions for use (IFU): Detailed guidance on use, storage, maintenance, disposal; may be separate booklet or electronic (eIFU for eligible devices).
• Warnings/cautions: Contraindications, precautions, residual risks.
• Sterility status: If sterile, indicate method (e.g., "STERILE EO") and "Do not use if package is damaged".
• Single-use or reusable: Clearly state if single-use ("Do not re-use") or reusable (with reprocessing instructions).
• Expiry/use-by date: Where applicable (format: YYYY-MM or YYYY-MM-DD).
• Storage conditions: Temperature, humidity, light protection if required.
• ARTG number: Include when supplied in Australia.

Special Cases

• Custom-made devices: Reduced labelling (e.g., patient identifier, prescriber details); full IFU not always required.
• Systems/procedure packs: Labelling must cover the entire pack and components.
• IVD devices: Additional requirements for calibration, control materials, and performance claims.
• eIFU eligibility: Certain high-risk devices may use electronic IFU if conditions met (accessible website, paper copy on request).

Compliance Considerations

• Labels must not be misleading or make unsubstantiated claims.
• Symbols: Use IEC 60417, ISO 15223-1, or ISO 7000 symbols with explanations in IFU if needed.
• Changes: Any labelling change affecting safety/effectiveness may require ARTG variation.
• Post-market: Monitor complaints related to labelling clarity or errors.

Detailed requirements for specific device types, symbol explanations, IFU content checklists, electronic labelling conditions, examples of compliant and non-compliant labels, and transitional arrangements are outlined in the TGA guidance on labelling medical devices to meet regulatory requirements. Source: Labelling medical devices to meet regulatory requirements - TGA

This guidance ensures users receive necessary information to use medical devices safely while supporting manufacturer compliance in the Australian market.