INOPP Forum
Reporting Issues Associated With Medical Devices
Quote from VigiServe Admin on November 26, 2020, 10:57 AMAnyone can report an issue associated with a medical device. An issue may relate to an adverse event, or a quality issue. Patients, caregivers, healthcare professionals and suppliers are all encouraged to lodge an adverse event report if an incident has occurred and there is a concern about the safety of the device or its use.
Send your report to devices@health.govt.nz
Reporting Timelines
It is important that adverse event reports are submitted to Medsafe promptly after the event and that a full description of the event is provided. Medsafe recommends that initial reports are filed within the timeframes below.
Death and Serious Injury (refer to definitions)
Please submit an initial report as soon as possible, and within 10 calendar days.
Submit a final report once the investigation has been completed.
If it is possible that death or serious injury could have occurred due to the incident, this should be reported following “death or serious injury” timelines.
Minor injury (refer to definitions)
If there could be a market action as a result of this incident (refer to the New Zealand Medicines and Medical Devices Recall Code), submit an initial report within 10 working days.
Please submit the final report within 120 calendar days. If the final report is not available at 120 days, submit an initial report.
Where possible, submit the report once the investigation has been completed in full.
Quality issue (refer to definitions)
If there could be a market action as a result of this incident (refer to the New Zealand Medicines and Medical Devices Recall Code), submit an initial report within 10 working days.
For all other quality issues, please submit a final report within 120 calendar days
Where possible, submit the report once the investigation has been completed in full.
Anyone can report an issue associated with a medical device. An issue may relate to an adverse event, or a quality issue. Patients, caregivers, healthcare professionals and suppliers are all encouraged to lodge an adverse event report if an incident has occurred and there is a concern about the safety of the device or its use.
Send your report to devices@health.govt.nz
Reporting Timelines
It is important that adverse event reports are submitted to Medsafe promptly after the event and that a full description of the event is provided. Medsafe recommends that initial reports are filed within the timeframes below.
Death and Serious Injury (refer to definitions)
-
Please submit an initial report as soon as possible, and within 10 calendar days.
-
Submit a final report once the investigation has been completed.
-
If it is possible that death or serious injury could have occurred due to the incident, this should be reported following “death or serious injury” timelines.
Minor injury (refer to definitions)
-
If there could be a market action as a result of this incident (refer to the New Zealand Medicines and Medical Devices Recall Code), submit an initial report within 10 working days.
-
Please submit the final report within 120 calendar days. If the final report is not available at 120 days, submit an initial report.
-
Where possible, submit the report once the investigation has been completed in full.
Quality issue (refer to definitions)
-
If there could be a market action as a result of this incident (refer to the New Zealand Medicines and Medical Devices Recall Code), submit an initial report within 10 working days.
-
For all other quality issues, please submit a final report within 120 calendar days
-
Where possible, submit the report once the investigation has been completed in full.
- You need to login to have access to uploads.