Recall and Field Safety Corrective Actions for Medical Devices in New Zealand

1. Legal and Procedural Framework

Recalls and field safety corrective actions (FSCAs) for medical devices in New Zealand are managed under a voluntary system guided by the Uniform Recall Procedure for Medicines and Medical Devices. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp There is no specific legislative requirement for mandatory recalls of medical devices under the Medicines Act 1981, unlike medicines. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

Sponsors (suppliers) are responsible for initiating and managing recalls when a device presents a risk to health or does not comply with essential principles of safety and performance. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

2. Uniform Recall Procedure

The Uniform Recall Procedure, maintained by the Ministry of Health, outlines the process for all therapeutic products including medical devices:

• Classification of recalls — Class I (high risk – immediate threat to life), Class II (moderate risk – temporary or reversible health effects), Class III (low risk – unlikely to cause health effects but non-compliant or misleading).
• Levels of recall — Trade level (wholesalers/distributors), Retail level (pharmacies/hospitals), Consumer level (patients/users).
• Actions — Product withdrawal, repair, modification, additional instructions for use, or destruction.

Sponsors must follow this procedure when conducting a recall or FSCA. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

3. Notification and Communication Requirements

When a recall or FSCA is initiated:

• The sponsor must notify Medsafe immediately.
• A recall strategy must be submitted, including classification, level, communication plan, and effectiveness checks.
• Sponsors issue recall notices to affected parties (distributors, users, healthcare professionals).
• Medsafe may publish recall notices on its website for public awareness.

For FSCAs not requiring full recall (e.g., updated instructions or software updates), sponsors must still notify Medsafe and affected users. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

4. Sponsor Responsibilities

Key obligations of the sponsor include:

• Assessing the need for corrective action based on risk.
• Implementing the recall/FSCA promptly and effectively.
• Maintaining records of distribution and actions taken.
• Verifying the effectiveness of the corrective action.
• Reporting completion of the recall to Medsafe.

Medsafe may monitor the process and request additional information or actions if compliance is inadequate. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

5. Medsafe's Role

Medsafe:

• Receives and reviews recall notifications and strategies.
• Provides guidance on classification and procedure.
• Publishes recall notices on its website when appropriate.
• May investigate non-compliance or safety issues under section 38 of the Medicines Act 1981.
• Coordinates with international regulators when recalls involve globally distributed devices.

Medsafe encourages proactive reporting of potential safety issues to prevent the need for recalls. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

6. Additional Notes

The page emphasizes that the voluntary nature of device recalls relies on sponsor responsibility and cooperation to ensure timely action. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

Links are provided to the current Uniform Recall Procedure document and recall notice templates. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

This framework supports effective post-market risk management for medical devices in New Zealand while aligning with international best practices. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp