If you are a sponsor of a medical device that is:
- an implantable Class IIb device; or
- a Class III device; or
- an active implantable medical device (AIMD); or
- a Class 4 in vitro diagnostic (IVD) device
then one of your automatic post-market obligations is to provide three consecutive annual reports to us after your device is included in the Australian Register of Therapeutic Goods (ARTG).
Annual reporting aims to ensure that:
- high risk devices that are new to the Australian market continue to meet the Essential Principles for safety and performance; and
- the post-market surveillance system is able to identify any safety or performance issues or signals associated with the device as early as possible.
Timing of annual reports
Annual reports should cover the period from 1 July to 30 June and are due on 1 October each year. Your first report should be for a period of at least six months, but not longer than 18 months. If the information is limited to the time the device has been on the Australian market because it hasn't been supplied elsewhere, this should be stated in the report. Subsequent reports are to be provided on 1 October for a further 2 years.
|Timing of ARTG inclusion||Annual report is due||Annual report must include data|
|Between 1 July and 31 December||1 October of the following year|| |
Data from 1 July of the preceding year to 30 June.
Example: XYZ Pty Ltd's medical device is included in the ARTG on 4 September 2016. Their first annual report will be due on 1 October 2017 as they will have over 6 months of data at 30 June 2017.
If XYZ's device is available in other countries, then their data must include global statistics from 1 July 2016.
If XYZ's device is not available in other countries, then their first annual report must include information from 4 September 2016 through to 30 June 2017.
|Between 1 January and 30 June||1 October of the following year||Data from the date of inclusion in the Register through to date to 30 June.|
Example: XYZ Pty Ltd's medical device is included in the ARTG on 20 January 2016. Their first annual report will be due on 1 October 2017 as they do not have 6 months of data available at 30 June 2016.
What should an annual report include?
Your annual report should contain the following information:
- ARTG number.
- Product name(s).
- Model number(s).
- Number of devices supplied in Australia by product/model.
- Number of devices supplied worldwide (numbers should include devices that are the same but supplied under a different name in another jurisdiction) by product/model.
- Number of complaints in Australia by product/model.
- Number of complaints by product/model.
- Number of adverse events and incident rates in Australia (Rate = No. of events/No. Supplied x 100 = Rate %).
- Number of adverse events and incident rates world-wide.
- A list of all complaints and adverse events identifying the jurisdiction where the complaint or adverse event originated.
- Device Incident Report (DIR) number of those adverse events reported to us.
- Details of any regulatory/corrective action/notification by the manufacturer.
Your annual report must also include all complaints received by the manufacturer relating to problems with the use of the device that have been received by them over the year. This includes complaints for the device where it is supplied in other countries under a different name.
How to submit your annual report
Annual reports must be provided in electronic form and can be emailed to IRIS@health.gov.au marked for the attention of the Annual Report Coordinator.
The TGA does not provide a reminder that your annual report is due. Annual reporting is an automatic condition of inclusion and failure to submit your report on time could result in the cancellation of your inclusion from the ARTG.
Your information should be presented in a clear and logical manner in a table format. The following is an example of how to present your annual report:
|ARTG #||Product name||Model #||# supplied in Aus||# supplied World Wide|| |
# of complaints
Aus / WW
# of Adverse Events
Aus / WW
|123456||Knee prosthesis - femoral component||ABC 123||200||8000||32/235||2/58|
|Type of complaints||Number||Percentage in Australia||Percentage world Wide||TGA DIR #||Regulatory action|
An annual report template that you can populate can be found at Template: Annual report data collection (xlsx,16kb).
What happens to annual reports?
Your report will be reviewed by us and we will contact you to request additional information or to work with you to resolve any issues that may are identified. If there are no issues with your report and no additional information is required, you will not be contacted.
All annual reports that are submitted to us are treated as confidential; however, the information contained within the report is used for the ongoing monitoring of the safety and performance of the devices.
|Version||Description of change||Author||Effective date|
|V1.0||Original publication||Medical Devices Branch||October 2019|