Recall Procedures for Medical Devices in New Zealand

1. Regulatory Framework for Device Recalls

Recalls and field safety corrective actions for medical devices in New Zealand are conducted on a voluntary basis, as there is no specific legislative power under the Medicines Act 1981 to mandate device recalls (unlike medicines). https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp Sponsors (suppliers) remain responsible for initiating and managing recalls when a device presents a risk to health or fails to comply with essential principles of safety and performance. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

2. Uniform Recall Procedure

All recalls follow the Uniform Recall Procedure for Medicines and Medical Devices, which defines:

• Classification — Class I (high risk – serious injury or death probable), Class II (moderate risk – temporary/reversible effects), Class III (low risk – unlikely to cause harm but non-compliant).
• Recall levels — Consumer (to patients/end-users), Retail (to pharmacies/hospitals), Trade (to wholesalers/distributors).
• Required actions — Product retrieval, repair, modification, additional instructions, or destruction.

Sponsors must adhere to this procedure for consistency and effectiveness. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

3. Notification and Strategy Requirements

When initiating a recall or field safety corrective action (FSCA):

• Sponsors must notify Medsafe immediately.
• Submit a detailed recall strategy including classification, level, communication plan, and effectiveness checks.
• Issue appropriate notices to affected parties (e.g., direct letters to consumers, trade notices to distributors).
• For FSCAs not requiring full recall (e.g., software patches, updated instructions), still notify Medsafe and users. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

4. Sponsor Responsibilities

Sponsors are expected to:

• Assess the need for corrective action based on risk evaluation.
• Implement the recall/FSCA promptly and effectively.
• Maintain records of distribution, actions taken, and effectiveness verification.
• Report completion of the recall to Medsafe. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

5. Medsafe's Oversight Role

Medsafe:

• Reviews and provides guidance on recall classifications and strategies.
• May publish recall notices on its website for public awareness.
• Monitors compliance and can investigate under section 38 of the Medicines Act 1981 if necessary.
• Coordinates with international regulators for globally affected devices. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

6. Practical Notes and Resources

The voluntary nature of device recalls relies on sponsor responsibility and cooperation. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

Medsafe provides links to the current Uniform Recall Procedure document and recall notice templates to assist sponsors in compliance. https://www.medsafe.govt.nz/regulatory/DevicesNew/8Recalls.asp

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