REGULATORY INFORMATION

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Information for Medical Device Suppliers

Closure of a Corrective Action

When the agreed action has been completed the sponsor should submit a final report on the action to close the investigation. The final report will also include details of the disposal or export of any affected product.

When to Close a Corrective Action
General Reporting Requirements
Recall Final Reports
Product Correction Final Reports
Download a Final Report Template

When to Close a Corrective Action

Before a final report is submitted by the sponsor the following should have occurred;

1. All actions agreed to between Medsafe and the sponsor have been completed
2. The root cause of the issue leading to the corrective action has been identified
3. The manufacturer has put in place corrective and preventative actions (CAPA) to prevent a recurrence of the issue leading to the corrective action

If these criteria have not yet been met a final report should not be submitted and the sponsor should continue to submit progress reports at monthly intervals until this information is available.

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General Reporting Requirements

All final reports should include the following information;

• The date that the corrective action notice was distributed
• A list of the affected customers and the date that each acknowledged receipt of the notice
• If the sponsor has not obtained a 100% response from the affected customers, details of the attempts made by the sponsor to obtain an acknowledgement should be provided
• Details of the root cause of the issue that led to the corrective action
• Details of the manufacturer's corrective and preventative action (CAPA) to prevent a recurrence of this issue
• Information about any difficulties experienced during the conduct of the corrective action

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Recall Final Reports

In addition to the above general reporting requirements sponsors closing recall actions should also provide;

• Details of the quantity of affected product returned by each customer
• The quantity of affected stock quarantined by the sponsor
• Confirmation that all of the affected product has been destroyed (i.e. copy of destruction certificate) or exported from New Zealand (i.e. copy of commercial invoice and airwaybill/shipping documents)

Destruction certificates may be obtained from the operators of medical waste firms and other waste management organisations operating secure landfills or other means of destruction.

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Product Correction Final Reports

In addition to the above general reporting requirements sponsors closing product correction actions should also provide;

• A serial number list of the affected devices detailing their location/customer and the date that each was modified/upgraded
• If the sponsor has not modified/upgraded 100% of the affected devices the sponsor should detail the missing units and the attempts made to locate them

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Download a Final Report Template

Medsafe has prepared a suggested corrective action final report template that sponsors may download and use when submitting their final reports. Use of the final report template is optional. Sponsors with their own reporting templates may continue to use their own forms.

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Download the corrective action final report template (Microsoft Word document 52 KB)

Page last updated 10 May 2011