Supplying and/or importing medical devices during supply disruptions or shortages

In 2026, the Therapeutic Goods Administration (TGA) made an instrument under section 41HD of the Therapeutic Goods Act 1989 (the Act). This instrument supports all Australians by reducing impacts to users when there are medical device supply disruptions or shortages. Medical devices supplied and/or imported under section 41HD are published on our website, allowing the public to access this information, supporting transparency under An Action Plan for Medical Devices. 

If a medical device included in the Australian Register of Therapeutic Goods (ARTG) is not available, we can grant temporary exemptions under section 41HD of the Act to allow the supply and/or import of medical devices not currently included in the ARTG in a time of critical need. 

An application to supply and/or import an alternative medical device, including in vitro diagnostic (IVD) medical devices, can be submitted using our online form. If approved, supplying and/or importing under section 41HD is a time-limited pathway, while the device included in the ARTG is not available. 

The section 41HD pathway is applicable for medical devices. If you need help to support a medicine shortage, please refer to the medicine shortages webpage.

Criteria for applications

Applications submitted under section 41HD of the Act must meet certain criteria, including: 

• No alternative devices available
  • there are no substitutes available in the ARTG 

OR

• ARTG included devices are also unavailable, in short supply or may become unavailable/in short supply in the reasonably foreseeable future.
• ARTG application/foreign registration or approval
  • The medical device has an application that has passed preliminary assessment for inclusion in the ARTG 

OR

• The medical device is registered or approved or use in at least one of the specified foreign countries.

The medical device is necessary in the interests of public health and safety.

Information to consider before applying

This pathway to supply and/or import medical devices is only for use in times of critical need.  Before seeking approval under section 41HD of the Act, you should consider whether other pathways for supplying and/or importing unapproved devices in Australia may be more appropriate including the Special Access Scheme, Authorised Prescriber Scheme and Personal Importation Scheme.

We do not have specified categories of medical devices requiring supply, you will need to demonstrate that there is a critical need for the medical device due to a disruption or shortage.

You will need to provide evidence of your relationship with or authorisation from the manufacturer to import and supply the medical device. The manufacturer will need to provide documentation to support the applicant throughout the application process.

You must hold evidence to demonstrate the manufacturer holds market authorisation in one of the countries specified in the determination, and to confirm the manufacturing and quality control procedures used in production are acceptable. Evidence to demonstrate this may include:

• notice of market authorisation from the national competent authority or regulatory body
• a certificate of conformity assessment, suitable for the medical device classification.

If the medical device has received market authorisation in an overseas country which is not specified in the determination, it may be considered in exceptional circumstances.

Section 41HD conditions of approval

Approvals under section 41HD are:

• subject to conditions to minimise risk to consumers, including:
  • informing us of any variation or if any information about the medical device becomes out of date
  • the labelling and instructions for use must be in English and include the approval holder’s name and address 
• time-limited, relative to the disruption or shortage the medical device is alleviating and may be revoked if circumstances change
• subject to the similar requirements as the medical devices included in the ARTG
  • e.g. maintenance of documentation, recording the source and supply of the medical devices, reporting of adverse events, providing samples of the medical device to us if requested, instigating market actions and advertising restrictions.

Submitting an application

Applicants can apply for approval using our online section 41HD application form.

An applicant does not need to already sponsor therapeutic goods in Australia or be the sponsor of the medical device(s) affected by disruption or shortage. Applicants can be an individual or a person and if successful, they are required to undertake the role of an Australian sponsor and hold evidence to support their application.

If you intend to supply the medical device on an ongoing basis, applying for approval under section 41HD does not replace the process of inclusion in the ARTG. See additional information about applications and market authorisation. 

Once the application form is submitted we will undertake a preliminary review and progress applications on a risk-basis. We may contact you for further information or evidence, if required. An outcome will be sent to you by email. 

Questions can be directed to MD.supplydisruptions@health.gov.au. Please cite your Response ID (generated from your application) in the subject line, if applicable.

How to prepare for your application

As an applicant, we expect you to hold evidence to support your application. If you claim to hold evidence and are unable to provide this within the timeframes requested via email, a decision will be made on your application based on the information available to the delegate. 

Completing the online application form

You will be asked to provide the following information to support your application:

• Supply disruption context, including why you are seeking approval
• Information about the availability of alternative devices included in the ARTG
• Details about the devices you are nominating to import/supply
• Any clinically relevant differences between the device included in the ARTG and the device you are applying to import/supply
• Evidence to demonstrate the benefits of importing/supplying the device not included in the ARTG outweigh the risks

Providing evidence

You will be asked to indicate the documented evidence you hold when completing the online form. When your application is reviewed, the following documents and information may be requested:

• Evidence to support justification (e.g. official notices or communications)
• Evidence of a relationship with the manufacturer (e.g. letter or agreement)
• Evidence of a foreign registration or marketing approval 
• Instructions for Use (IFU), Patient Implant Cards (PICs) or Patient Information Leaflets (PILs), if applicable
• Clear, good quality photographs of all labels and text on the nominated device(s) and/or packaging, including any supplemental labels
• Clinical evidence
• Risk assessment documentation

Publication of approvals

Medical devices approved for import and/or supply under 41HD are published on our website, about 41HD approvals for import and supply.

This webpage allows the public to access information about each approval, including details on the device and models available as alternative devices.

Legal requirements for approval