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November 16, 2025
Approximately 5 minutes
Australia Medical Device Labeling: TGA Compliance and Sponsor Requirements
Australia Medical Device Labeling: TGA Compliance and Sponsor Requirements
Medical device labeling in Australia is strictly regulated by the Therapeutic Goods Administration (TGA) and must comply with the Therapeutic Goods (Medical Devices) Regulations 2002. Proper labeling is essential for demonstrating adherence to the Essential Principles of safety and performance, which is mandatory for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Mandatory Sponsor and Manufacturer Information
A key requirement for market access is the clear identification of the responsible parties:
- Australian Sponsor Details: The name and address of the Australian Sponsor (the local authorized representative) must appear on the outer packaging label. This information can be added before or after customs clearance and is exempt from current Good Manufacturing Practice (GMP) requirements.
- Manufacturer Details: The name, trading name, and address of the manufacturer must be included.
Essential Label Content
Labels (including those on the device, outer packaging, and Instructions for Use) must contain sufficient information for the user to identify the product and use it safely. This includes:
- Intended Use: A clear description of the intended use, including the type of user and the kind of patient for whom the device is intended (if not obvious).
- Safety and Warnings: Mandatory warnings, restrictions, or precautions required for the safe and proper use of the device.
- Handling and Storage: Any necessary handling, storage, or operating instructions.
- Traceability: A batch code, lot number, or serial number for identification.
- Dates: A clear statement of the expiration date (month and year) if applicable, and the date of manufacture if not provided elsewhere.
- Usage Statement: If applicable, a statement indicating the device is for single use only.
Specific Labeling Requirements
- Sterile Devices: Must include the word “STERILE” and clearly state the sterilization method used.
- Custom-Made Devices: A statement must indicate that the device is intended for use only by the specific health professional or individual for whom it was custom-made.
- Devices Under Clinical Investigation: For medical devices undergoing pre-market clinical investigation or performance evaluation (including IVD devices), the label must clearly state their intended use for these purposes.
- Export Only: If the device is exclusively for export, the label must clearly state “for export only”.
Adherence to these precise labeling requirements ensures traceability, safety, and regulatory compliance for all medical devices imported into and supplied within the Australian market.
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