provide the TGA with six-monthly reports detailing the supply of unapproved devices to Authorised Prescribers consider whether to submit an application to the TGA if long-term supply of device is expected monitor the use of their devices report to the TGA all those serious unanticipated device related adverse events of which they have been informed. For more information, please see Adverse event reporting requirements for clinical trials. communicate rapidly to the TGA information that has an important bearing on the benefit–risk assessment of the device, particularly any information that may lead changes to the usage of the device by Authorised Prescribers Adverse reporting requirements for Authorised Prescribers Reporter What needs to Who to report In what Timeframe be reported to format? Authorised Any adverse TGA Medical Device As promptly as possible, to reach TGA Prescriber device event Incident within 15 days Report form Sponsor As required by As required by sponsor sponsor HREC (if As required by As required by HREC applicable) HREC Sponsor Serious TGA Medical Device fatal or life-threatening adverse unanticipated Incident device events—initial report within 7 adverse device Report form calendar days of first knowledge. related events Complete report within 8 additional calendar days serious unanticipated device events, full report no later than 15 calendar days of first knowledge Other adverse TGA Tabulation/ On request by TGA device events Line listing For reports to the TGA, the report should be clearly marked 'Authorised Prescriber Incident' and sent to: The Medical Officer Clinical Section Office of Devices Authorisation Therapeutic Goods Administration PO Box 100 WODEN ACT 2606 Australia The Medical Device Incident Report form is available on the TGA website: <>.
provide the TGA with six-monthly reports detailing the supply of unapproved devices to Authorised Prescribers consider whether to submit an application to the TGA if long-term supply of device is expected monitor the use of their devices report to the TGA all those serious unanticipated device related adverse events of which they have been informed. For more information, please see Adverse event reporting requirements for clinical trials. communicate rapidly to the TGA information that has an important bearing on the benefit–risk assessment of the device, particularly any information that may lead changes to the usage of the device by Authorised Prescribers Adverse reporting requirements for Authorised Prescribers Reporter What needs to be reported Who to report to In what format? Timeframe Authorised Prescriber Any adverse device event TGA Medical Device Incident Report form As promptly as possible, to reach TGA within 15 days Sponsor As required by sponsor As required by sponsor HREC (if applicable) As required by HREC As required by HREC Sponsor Serious unanticipated adverse device related events TGA Medical Device Incident Report form fatal or life-threatening adverse device events—initial report within 7 calendar days of first knowledge. Complete report within 8 additional calendar days serious unanticipated device events, full report no later than 15 calendar days of first knowledge Other adverse device events TGA Tabulation/ Line listing On request by TGA For reports to the TGA, the report should be clearly marked 'Authorised Prescriber Incident' and sent to: The Medical Officer Clinical Section Office of Devices Authorisation Therapeutic Goods Administration PO Box 100 WODEN ACT 2606 Australia The Medical Device Incident Report form is available on the TGA website: <>.
devices-argmd-p2.docx