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