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Export certification for medical devices
About this guidance
This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
If you plan to export a medical device from Australia, you must meet certain regulatory requirements set out in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, in addition to other relevant Commonwealth and state or territory legislation. Criminal and civil penalties may apply if you do not meet these legal requirements.
For additional information about medical devices and IVDs refer to Medical devices & IVDs.
- About this guidance
- ARTG inclusion
- Export certification for medical devices
- Certificate of Free Sale
- Export Certificate
- Eligibility to apply for a certificate
- Information included on a certificate
- Product details
- Sponsor and manufacturing details
- Importing country
- How your certificate will look
- Before applying for a certificate
- Check the importing country’s requirements
- Check the ARTG details are current and correct
- Application process
- Information needed from applicants
- Manufacturer of the device
- Schedule of devices
- Application form
- Incorrect or incomplete applications
- Sponsor declaration
- Electronic or hard copies
- Receiving your certificate
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