WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.3-AR: A manufacturer outside the jurisdiction appoints a local authorized representative, under an agreement setting out who meets each national requirement and keeps distribution records

What does 6.2.3-AR require?

Because foreign manufacturers rarely have a presence in each country, the law should require a manufacturer outside the jurisdiction to appoint an authorized representative there. The two should sign an agreement defining which party fulfils each national regulatory requirement and keeps records of the device's distribution, and obliging the representative to forward every incident, adverse event and item of user feedback (complaints included) to the manufacturer so it can investigate and, if needed, correct.