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Medical Device Documents for Download

All documents relating to medical devices which are available for download from the Medsafe website are linked below.

WAND Forms and Manual
Recalls and Corrective Actions
Adverse Event Reporting

WAND Forms and Manual
Download an Access to WAND Application Form (Microsoft Word document 95KB)
Download the sponsor details update form (Microsoft Word document 69 KB)
Download the WAND administrator details update form (Microsoft Word document 51 KB)
Download the WAND User Manual (Adobe PDF document 297KB)

Recalls and Corrective Actions
Download the Uniform Recall Procedure Code (Adobe PDF document 995KB)
Download a Notice of Corrective Action form (Microsoft Word document 67KB)
Download the Medical Device Recall notice template (Microsoft Word document 36KB)
Download the Medical Device Recall for Product Correction notice template (Microsoft Word document 40KB)
Download the Safety/Hazard Alert template (Microsoft Word document 35KB)
Download the Corrective Action Progress Report template (Microsoft Word document 52KB)
Download the Corrective Action Final Report template (Microsoft Word document 52KB)

Adverse Event Reporting
Download the Sponsor and Manufacturers Adverse Event Reporting form (Microsoft Word document 153KB)
Download the General Adverse Event Reporting form (Microsoft Word document 139KB)

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Page last updated 10 October 2011