New Zealand In Country Sponsor Representation
- Register your devices with Medsafe before they are commercialized and notify Medsafe of any changes
- Maintain your Technical File or Design Dossier Note: we will only release this information to Medsafe with your written approval
- Assist in incident reporting to Medsafe, in close liaison with you and your distributors
- Notify Medsafe as to which investigations are to be conducted.
- Assist in device recall
- Act as your primary regulatory liaison with Medsafe, including notifications of incidents reported to Medsafe