Exporting medical devices

4 September 2018

Please note: from 4 September 2018 the certificate of free sale and export certificate application form has been updated. Please use the updated application form from this date. Thank you

Sponsors that wish to export medical devices from Australia must meet certain regulatory requirements set out in the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 .

Please see the Australian Regulatory Guidelines for Medical Devices (ARGMD), Part 2, Section 17, for further information on exporting medical devices for commercial purposes.

When exporting medical devices, sponsors may be asked by the importing country to supply a "certificate of free sale" or an "export certificate". Certificates of free sale and export certificates are documents supplied by the Therapeutic Goods Administration (TGA) outlining that the relevant medical device(s) are included in the Australian Register of Therapeutic Goods (ARTG) and are either able to be freely supplied and sold within Australia or are able to be exported from Australia.

Please see our guidance Certificates of free sale and export certificates for medical devices for further information regarding certificates of free sale and export certificates.

To apply for a certificate of free sale or an export certificate, please fill out the Application for certificate of free sale / export certificate for a medical device.