WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.3.1.1-AR-duties: As authorized representative, give the NRA business and contact details, list devices and keep the list current, support authorization applications, relay feedback and FSCA, cooperate with importers, distributors and the NRA and see that users are trained

What does 6.2.3.1.1-AR-duties require?

At minimum the authorized representative should register its place of business, responsible person, contact details and the manufacturers it represents. Regulation may require it to undertake to act for the manufacturer with the NRA by listing the devices it places on the national market and keeping the list current with renewals and withdrawals; providing the information the NRA needs when the manufacturer seeks authorization; sending the manufacturer every piece of user feedback about adverse events, incidents and complaints (and, in some countries, reporting those events to the NRA itself); making sure users such as hospitals and pharmacies act on the manufacturer's field safety corrective actions, and in some jurisdictions reporting those actions; working with the manufacturer's distributors and importers; seeing that user training is delivered as the manufacturer requires; and cooperating with the NRA during market surveillance.