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
|Allow entry and inspections of premises|| ||Section 41FN(1)|
|Deliver samples upon request|| ||Section 41FN(2)|
|Availability of information|| ||Section 41FN(3)|
|Advertising material|| ||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|| ||Section 41FN|
|Report results of investigations undertaken by the manufacturer to the TGA|| ||Section 41FN|
|Assist the TGA and the manufacturer in investigations if an incident occurs|| ||Section 41FN|
|Take corrective action when necessary|| ||Section 41KA|
|Maintain distribution records for product supplied in or exported from Australia|| || |
|Conditions imposed when medical devices are included in the ARTG|| ||Section 41FO(2)|
Recalls, suspensions, cancellations, and tampering of medical devices
- Recalls, suspensions, cancellations, and tampering of medical devices (including IVD medical devices)
- Uniform recall procedure for therapeutic goods (URPTG)
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'.