Australia

As your Sponsor, Asia Actual Australia will also ensure that your labeling is compliant with TGA requirements as they pertain to your specific product.

The Australia Sponsor’s name and address is required on the outer packaging label. The labeling can be placed on the packaging before, or after the shipment has been cleared through Customs. This Sponsor labeling step is exempt from the current GMP requirements.

Product labeling will need to include the following:

1. The manufacturer’s name, or trading name, and address
2. The intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used (if this information is not obvious)
3. Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging
4. Handling or storage requirements applying to the device
5. Any warnings, restrictions, or precautions that should be taken, in relation to use of the device
6. Any special operating instructions for the use of the device
7. If applicable, an indication that the device is intended for a single use only
8. If applicable, an indication that the device has been custom‑made for a particular individual or health professional and is intended for use only by that individual or health professional
9. If applicable, an indication that:
   1. if the device is a medical device other than an IVD medical device-the device is intended for pre‑market clinical investigation; or
   2. if the device is an IVD medical device-the device is intended for performance evaluation only
10. For a sterile device, the word ‘STERILE’ and information about the method that was used to sterilize the device
11. The batch code, lot number or serial number of the device
12. If applicable, a statement of the date (expressed in a way that clearly identifies the month and year) up to when the device can be safely used
13. If the information provided with the device does not include the information mentioned in item 12-a statement of the date of manufacture of the device (this may be included in the batch code, lot number or serial number of the device, provided the date is clearly identifiable)
14. If applicable, the words ‘for export only’

Contact Asia Actual for more information on specific Australian labeling requirements.