Importing Medical Devices Into Australia

Importing & supplying medical devices | Therapeutic …

https://www.tga.gov.au/resources/resource/guidance/importing-supplying-medical-devices

The Therapeutic Goods Administration (TGA) regulates all medical devices that are imported into, supplied in or exported from Australia under the Therapeutic Goods Act 1989 (the Act). Unless a specific exemption applies, medical devices must be …

Entering Australia | Therapeutic Goods Administration …

https://www.tga.gov.au/entering-australia

Coming to Australia with medicines and medical devices. There are rules about bringing medicines and medical devices into Australia. Many medicines and …

Australia - Medical Devices - International Trade …

https://www.trade.gov/country-commercial-guides/australia-medical-devices

Medical import permit details | ARPANSA

https://www.arpansa.gov.au/regulation-and-licensing/licensing/import-export-permits/medical-import-permits

Contact. Under the Customs (Prohibited Imports) Regulations, a permit from the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is required for the import of …

Australian Regulatory Guidelines for Medical Devices …

https://ablis.business.gov.au/service/ag/australian-regulatory-guidelines-for-medical-devices-argmd-/30938

manufacture medical devices in Australia for export to overseas markets; manufacture medical devices overseas for import into the Australian market. The guidelines provide …

FAQS on getting your therapeutic goods and medical …

https://www.abdera.com.au/faqs-on-getting-your-therapeutic-goods-and-medical-devices-approved-for-sale-in-australia/

In Australia, therapeutic goods must be approved and included on the Australian Register of Therapeutic Goods (ARTG) before they can be sold to Australian consumers and the …

Australia - Import Requirements and Documentation

https://www.trade.gov/country-commercial-guides/australia-import-requirements-and-documentation

Political & Economic Environment. Import Requirements and Documentation. Includes import documentation and other requirements for both the U.S. exporter and …

Travellers | Office of Drug Control (ODC)

https://www.odc.gov.au/travellers

Travellers. Find out how to travel into or out of Australia with prescription medicines, cannabis products, kava or other controlled substances. We have information for yourself …

Importing and Exporting Medical Devices | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/importing-and-exporting-medical-devices

Importing and Exporting Medical Devices. Foreign establishments that manufacture medical devices and/or radiation-emitting electronic products that are …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

The following is an example of a medical device classification search for a manual toothbrush. Depending on the Class of the medical device you are importing, the …