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January 12, 2026
Approximately 5 minutes
Adverse Event Reporting for Medical Devices in New Zealand
Adverse Event Reporting for Medical Devices in New Zealand
1. Purpose of Adverse Event Reporting
Adverse event reporting is a key component of post-market safety monitoring for medical devices in New Zealand. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp Reports help Medsafe identify potential safety issues, assess risks, detect emerging signals, and take appropriate action to protect public health. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
The system is voluntary but strongly encouraged for healthcare professionals, patients, consumers, and sponsors (suppliers). https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
2. What to Report
Reports should include any incident where a medical device:
- Has caused or contributed to death or serious injury
- May have caused or contributed to a serious deterioration in health
- Has malfunctioned or performed inadequately, potentially leading to harm if the malfunction recurs
- Has quality defects or issues affecting safety or performance
Near misses, where harm was narrowly avoided, and complaints about device quality or labelling are also valuable. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
3. How to Report
Adverse events can be reported to the Centre for Adverse Reactions Monitoring (CARM) by:
- Online form (preferred method)
- Email to carm@otago.ac.nz
- Post to CARM, University of Otago Medical School
Reporters are asked to provide as much detail as possible, including device details (brand, model, serial/lot number), patient information (age, sex, outcome), event description, and reporter contact details. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
4. Confidentiality and Follow-up
All reports are treated confidentially. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp CARM may contact reporters for additional information to assist in assessment. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
Personal information is protected under the Privacy Act 2020, and reports are de-identified when shared or published. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
5. Processing and Outcomes
CARM reviews each report, assesses causality and severity, and enters data into a national database. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp Medsafe analyses aggregated reports to identify trends or signals requiring further investigation, which may lead to:
- Safety alerts or communications
- Requests for additional information from sponsors
- Field safety corrective actions or recalls
- Changes in regulatory status or usage recommendations
Serious reports may prompt rapid assessment and international information sharing. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
6. Sponsor Responsibilities
Sponsors must notify Medsafe of significant adverse events or trends they become aware of, particularly those indicating a serious risk or requiring corrective action. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp Sponsors are encouraged to investigate reported issues and implement appropriate measures. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
7. Importance of Reporting
Public participation in adverse event reporting strengthens device safety surveillance in New Zealand. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp Every report contributes to better understanding of real-world device performance and helps prevent harm to future patients. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
Medsafe thanks all reporters for their valuable contribution to medical device safety. https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp
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