Medical device manufacturers and sponsors operating in Australia must ensure their products meet strict regulatory standards. The Therapeutic Goods Administration (TGA) has updated its guidance in 2024 to clarify how the labelling requirements should be applied in practice. For businesses navigating the complexities of compliance, understanding these updates is essential to avoid regulatory pitfalls and ensure that devices are correctly labelled for the Australian market.
This post explains who is responsible for medical device labelling, what information must be included, and how to meet the TGA’s expectations.
Please note: While we strive to keep this information accurate and up to date, regulatory requirements can change. This article serves as a useful guide, but for legally binding information, always refer to the latest official guidance and regulations published by the TGA.
Who Is Responsible for Labelling?
The Manufacturer’s Role
The manufacturer is the company or individual responsible for the design, production, packaging, and labelling of a medical device. This means the manufacturer must ensure that all required information appears on the device and that it complies with Essential Principle 13 of the Therapeutic Goods (Medical Devices) Regulations 2002.
Manufacturers must also keep records proving that their devices meet regulatory standards. This includes documentation on labelling, packaging, and instructions for use, which may be requested by the TGA during audits or compliance checks.
The Sponsor’s Role
A sponsor is the Australian-based company or individual that registers a medical device with the Australian Register of Therapeutic Goods (ARTG) and is responsible for ensuring it complies with local regulations. While sponsors do not manufacture the device, they must ensure their name and address appear on the product.
If it is impractical to include sponsor information directly on the device, it must be placed on the packaging or in an accompanying leaflet. However, sponsors cannot alter the manufacturer’s original label in a way that obscures essential details. The TGA has made it clear that relabelling under a manufacturer’s instructions does not make a company a manufacturer.
What Information Must Be Included on the Label?
Labelling requirements for medical devices are strict because they ensure safe and effective use. Every medical device supplied in Australia must have clear, accurate, and comprehensive labelling that includes:
Manufacturer’s Details
The label must clearly display the manufacturer’s name, trading name (if applicable), and physical address. This ensures that regulators and users can identify the responsible party in case of safety concerns, recalls, or compliance checks.
Device Identification and Intended Use
A medical device label must enable users to accurately identify the product and understand its intended function. This includes:
- The device’s intended purpose—what it is designed to do and under what conditions it should be used.
- The intended user, which could be healthcare professionals, patients, or caregivers.
- The patient group the device is designed for, if not immediately obvious.
If the intended use is not self-explanatory, additional details must be provided in a way that ensures clarity.
Product Identification and Traceability
To prevent misidentification and support recall procedures, every medical device must include:
- Model number, reference code, barcode, or other unique identifier.
- Batch code, lot number, or serial number to track the device throughout its lifecycle.
Storage and Handling Instructions
Certain medical devices require specific conditions for storage, transport, or handling to maintain their safety and effectiveness. The label must specify conditions such as:
- Temperature or humidity limits
- Protection from light, moisture, or contaminants
- Any other environmental factors that could affect performance
Warnings, Restrictions, and Precautions
If a device has any safety concerns, contraindications, or potential risks, these must be explicitly stated. Restrictions on use—such as limitations for certain patient groups or medical conditions—should also be highlighted.
Software as a Medical Device (SaMD)
Software that qualifies as a medical device (SaMD) is subject to labelling requirements similar to traditional medical devices. Manufacturers must ensure that software versions, cybersecurity features, and intended uses are clearly documented. Compliance with both Australian regulations and international standards (such as GSPR 23) can streamline market entry into multiple regions.
Practical Tips for Medical Device Labelling Compliance
- Improve Label Visibility
- Optimize label placement by consulting end-users, such as healthcare professionals.
- Ensure critical information is highlighted using bold text or colour differentiation.
- Use QR codes to link to additional regulatory and usage information.
- Ensure Labelling Accuracy and Durability
- Conduct human factors testing to minimize errors.
- Maintain version-controlled documentation.
- Test labels under extreme conditions for long-term readability.
- Prepare for Global Markets
- Design labels that align with multiple regulatory standards from the outset.
- Avoid costly redesigns when expanding internationally.
- Ensure Software Compliance
- Clearly indicate software versions, release updates, and cybersecurity measures in documentation and user interfaces.
- Leverage Digital Labelling
- Utilize in-app notifications or splash screens to provide real-time regulatory updates.
- Maintain an accessible online repository of software manuals and regulatory information.
- Support Regulatory Audits
- During an MDSAP audit, regulatory authorities may require proof that labelling aligns with agreements between manufacturers and sponsors.
- Providing recent photographs of packaging has been sufficient in past inspections.
By implementing these strategies, manufacturers and sponsors can navigate compliance requirements more efficiently, ensuring smooth regulatory approvals and market access in Australia.
