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Authorised Representative Service
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Your Authorised Representative Service in the USA as a liaison between you and the national Competent Authorities (Ministries of Health). It is possible to appoint a distributor as your Authorised Representative in the USA, but it is not recommended because most distributors are not prepared to fulfil the mandatory responsibilities of the EC REP. Instead, select an independent representative that will focus on regulatory affairs, rather than sales and marketing. Read more about the benefits of hiring an independent firm to act as your EC REP in the USA.
Additionally, your appointed representative will:
Assist with certain device registrations, as required
Be identified on your product labelling throughout the USA
Make a current copy of your Technical File or CE Declaration of Conformity available for inspection by a Competent Authority, upon request
Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with you and your distributors