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Personal Importation

Overview​

Australian residents may import unapproved therapeutic goods — including medical devices — for their own personal use, subject to specific limits and conditions. This is known as the personal importation exemption. It is a narrow exemption from the general requirement that therapeutic goods must be included in the ARTG before they can be supplied in Australia. It does not extend to importing for other people, for commercial purposes, or for supply.

The personal importation provisions are set out in Regulation 12 of the Therapeutic Goods Regulations 1990.

What the Personal Importation Exemption Allows​

A person may import an unapproved medical device for their own personal therapeutic use if:

  • The goods are imported by the person for their own use — not for supply to others
  • The quantity imported is consistent with personal use (not a commercial quantity)
  • The goods are not prohibited imports under other Australian law (e.g., Customs legislation)
  • The goods are not steroids, hormones, or other specifically restricted substances (more relevant to medicines than devices)

Practical examples where personal importation is generally permitted:

  • A person importing a continuous glucose monitor not yet available in Australia
  • A person importing a specific orthopaedic support device not on the ARTG
  • A traveller returning to Australia with a medical device they regularly use

Key Limitations​

Not for supply to others​

The personal importation exemption applies only to the importing individual. Once imported, the device cannot be supplied to another person — even informally, even to a family member, and even without payment. Supplying an unapproved device to another person would constitute an offence under the Therapeutic Goods Act 1989, regardless of the circumstances.

Quantity limits​

Imports must be in quantities consistent with personal use. The TGA does not specify an exact quantity limit for devices in the way it does for medicines, but importing in bulk quantities that suggest commercial intent will not be protected by the personal importation exemption.

No quality assurance​

Devices imported under the personal importation exemption have not been assessed by the TGA for safety or performance. The importer assumes all risk. There is no guarantee that the device meets the Australian Essential Principles or that it is genuine, not counterfeit, or not defective.

When Personal Importation Becomes Supply​

The most important risk for health professionals and others who import devices is inadvertently becoming a sponsor. Under Australian law, a person who imports a medical device and:

  • Administers it to a patient, or
  • Supplies it to another person for use, or
  • Uses it as part of providing a health service

...may be considered to have supplied the device in Australia and thus to be the sponsor — with all associated regulatory obligations including ARTG inclusion.

Health professionals who import unapproved devices for use in their practice are frequently unaware that this makes them the sponsor of an unapproved device, which is a serious offence.

👉 Importers and Distributors 👉 Sponsors

Importing for Other People — Not Permitted Under Personal Importation​

Importing an unapproved device on behalf of another person — even a family member, even without profit — is not covered by the personal importation exemption. If a person needs access to an unapproved device, the appropriate pathways are:

  • SAS Category B — apply to the TGA for individual patient approval
  • SAS Category A — for seriously ill patients where no alternative exists
  • Authorised Prescriber — for practitioners with recurring clinical need

👉 Special Access Scheme

quantities of unapproved devices at the border may trigger further investigation, and goods may be detained pending TGA clearance. Importers should declare medical devices to the ABF and be prepared to demonstrate that the quantity and intended use fall within the personal importation exemption. Devices that appear counterfeit or non-compliant with Essential Principles may be seized regardless of the personal importation exemption.​

The Australian Border Force (ABF) enforces import restrictions at the border. While the TGA personal importation exemption may apply in principle, goods may still be subject to inspection at the border. Bringing large quantities of medical devices through customs — even for genuine personal use — may attract scrutiny.

If goods are seized at the border, the importer must be able to demonstrate the goods are for personal therapeutic use. Prescription documentation or a letter from a treating practitioner can assist in demonstrating this.

Risks of Personal Importation​

Devices imported under the personal importation exemption carry risks the importer should be aware of:

  • No Australian regulatory oversight — the device has not been assessed for safety or performance by the TGA
  • Counterfeit risk — particularly for devices purchased online from overseas suppliers
  • No warranty or recourse — Australian consumer law may not apply to goods purchased from overseas
  • Adverse event reporting — if something goes wrong, there is no sponsor to report the adverse event, and no TGA follow-up process
  • No patient implant card — for implantable devices, the patient may lack documentation needed for future medical care

Official Sources​