Manufacturing medical devices in Australia for export to overseas markets
Manufacturers wishing to apply for an export only medical device, need to have the device included on the Australian Register of Therapeutic Goods (ARTG) as a Class I medical device.
If a medical device is for export only and the manufacturer does not already have the device included on the ARTG, refer toHow to make an application through DEAL.
Manufacturers wishing to supply their devices in Europe may obtain a CE Certificate from the TGA, through the MRA process. Refer toAustralian Regulatory Guidelines for Medical Devices (ARGMD)for more information.
If your product is already on the ARTG and a manufacturer wishes to export to overseas markets, refer toimporting/exporting for commercial purposes.
Thats how I read it too.
