Importing Unapproved Medical Devices FAQs

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Why are unapproved medical devices a risk in Australia?

Unapproved devices may not meet Australian safety and performance standards, leading to patient harm, misdiagnosis, or equipment failure.

Are international certifications like FDA or CE enough for use in Australia?

No. These certifications only apply in their respective regions. In Australia, devices must be registered with the Therapeutic Goods Administration (TGA) and listed on the Australian Register of Therapeutic Goods (ARTG).

What is the role of the TGA in medical device compliance?

The TGA regulates all medical devices in Australia. Only products listed on the ARTG and imported by a registered sponsor can be legally supplied and used.

What are the legal consequences of importing unapproved devices?

Australian Border Force can seize non-compliant devices at customs. Clinics may face fines, audits, and loss of insurance coverage.

Can clinics import devices directly if they find them on ARTG?

No. Only a registered TGA sponsor can legally import devices. Clinics must work through an existing sponsor or apply to become one.

What patient safety risks do unapproved devices pose?

They may cause misdiagnosis, burns, radiation exposure, or other serious health issues due to inadequate testing and calibration.

Do imported devices come with local warranty and support?

Often not. Many overseas devices lack Australian-based servicing or warranty options, leaving clinics with costly, unusable equipment.

How does using unapproved devices affect insurance?

Professional insurance can be voided if non-approved devices are used, exposing clinics to financial and legal risks.

How can clinics verify if a device is approved?

Check the ARTG listing, request proof of TGA approval from suppliers, and consult compliance experts.

What should patients ask before treatment?

Patients should ask for the device’s brand and model, verify it on the ARTG, and ensure it is legally approved for use in Australia.

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