Safety Monitoring of Medical Devices in New Zealand

1. Overview of Post-Market Safety Monitoring

Medsafe is responsible for ongoing safety monitoring of medical devices after they are supplied in New Zealand. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp This post-market surveillance helps identify emerging safety issues, assess risks, and take appropriate action to protect public health. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

Unlike pre-market assessment, post-market monitoring relies on real-world use data collected through adverse event reports, international information, and other sources. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

2. Adverse Event Reporting System

Healthcare professionals, patients, and sponsors are encouraged to report adverse events, near misses, and quality issues related to medical devices to the Centre for Adverse Reactions Monitoring (CARM). https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

Reports can be submitted online, by email, or post. CARM reviews reports, assesses causality and severity, and may request additional information from reporters or sponsors. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

Medsafe analyses aggregated data to detect safety signals that may require further investigation or regulatory action. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

3. International Safety Information

Medsafe monitors safety alerts, field safety notices, recalls, and regulatory actions from international authorities such as:

• Therapeutic Goods Administration (TGA) – Australia
• Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom
• Food and Drug Administration (FDA) – United States
• European Medicines Agency (EMA) and other national competent authorities

Relevant international information is reviewed and, where appropriate, communicated to New Zealand stakeholders via safety alerts or website updates. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

4. Safety Communications and Alerts

When a safety issue is identified, Medsafe may issue:

• Device Safety Alerts – Urgent communications about serious risks requiring immediate action.
• Prescriber/Healthcare Professional Updates – Information for clinicians on emerging risks or changes in recommendations.
• Consumer Information – Patient-focused advice on device safety and what to do if problems occur.

These communications are published on the Medsafe website and distributed to relevant parties. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

5. Collaboration with Sponsors

Sponsors (suppliers) play a key role in post-market safety:

• They must notify Medsafe of any field safety corrective actions (FSCAs), recalls, or significant safety issues.
• Sponsors are expected to investigate reported problems, implement corrective measures, and provide follow-up information.
• Medsafe may request additional post-market surveillance data or risk management plans from sponsors for high-risk or novel devices. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

6. Continuous Improvement and Compliance

Medsafe periodically reviews the safety profile of devices, particularly higher-risk ones, and may request sponsors to conduct additional studies or provide periodic safety update reports. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

Non-compliance with safety obligations can lead to regulatory action under section 38 of the Medicines Act 1981, including investigations or restrictions on supply. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp

This proactive, multi-source monitoring system ensures timely detection and response to device safety issues in New Zealand. https://www.medsafe.govt.nz/regulatory/DevicesNew/safety-monitoring.asp