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Medical device inclusion process

Steps in the process

11 October 2019

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Step 9 - Ongoing responsibilities

As a sponsor of a medical device, or IVD medical device, included in the ARTG you have ongoing responsibilities. For further information refer to related information and guidance below.

Conditions of inclusion

If there are specific conditions of inclusion relating to your product, you will be notified at the time of inclusion.

Post market vigilance and monitoring

Requirement Example(s) Legislative reference
Allow entry and inspections of premises
  • Allowing a person authorised by the TGA to enter and inspect any premises, including outside Australia, where the devices are manufactured or located.
  • While on the premises, allowing a person authorised by the TGA to inspect the premises and medical devices on the premises.
  • Allowing a person authorised by the TGA to take samples of medical devices from the premises.
Section 41FN(1)
Deliver samples upon request
  • Providing samples of the medical device to the TGA upon request.
Section 41FN(2)
Availability of information
  • Facilitating access to the technical documentation that demonstrates compliance with the Essential Principles.
  • Facilitating access to the evidence that appropriate conformity assessment procedures have been applied.
  • Providing this information to the TGA within specified timeframes when requested.
Section 41FN(3)
Advertising material
  • Ensuring any advertising material relating to the medical device complies with regulatory requirements.
Section 41FN(5)
Report details of certain incidents and performance issues to the TGA Section 41FN(3)(d)
Report any overseas regulatory actions to the TGA if the product involved is from the same batch or production run that was supplied in Australia
  • When an adverse event has occurred with a product in another country and the ensuing investigation by the manufacturer determines that a batch of the product should be recalled. If the batch is supplied in Australia the sponsor should notify the TGA of the overseas action to determine if the same action should occur in Australia.
Section 41FN
Report results of investigations undertaken by the manufacturer to the TGA
  • Relay the results to the TGA of an investigation into a returned sample associated with an adverse event report.
Section 41FN
Assist the TGA and the manufacturer in investigations if an incident occurs
  • Passing information to the TGA and the manufacturer during an investigation of an adverse event.
  • Assisting in the gathering of information and samples from the user.
Section 41FN
Take corrective action when necessary
  • Recalling medical devices.
  • Informing the public about medical devices that do not comply with requirements.
Section 41KA
Maintain distribution records for product supplied in or exported from Australia
  • Records of delivery to:
    • distribution warehouses
    • manufacturing sites
    • retails outlets

Section 41FO

Regulation 8.1(b)

Conditions imposed when medical devices are included in the ARTG
  • Provide annual reports for the first three years a Class III, AIMD, or Class IIb implantable device is available in Australia.
Section 41FO(2)

Recalls, suspensions, cancellations, and tampering of medical devices

Annual charges

There are ongoing Annual charges associated with maintaining your inclusion on the ARTG. The annual charge associated with your inclusion on the ARTG is available through the Schedule of fees and charges webpage under 'Medical Devices' or 'IVD Medical Devices'.

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