How do we choose between an agent, distributor and an independent Authorized Representative?
• Consider the following: • Do you want your distributor to focus on sales & marketing or on regulatory affairs? • Will your distributor in country A object if the name and address of your distributor in country B appears on all devices, inserts and packaging? • Will it lead to distribution/warranty confusion if the name and address of distributor A appears on your devices in all EU States? • If you change distributors will it be costly to change all device labels, inserts and packaging? • Do you feel comfortable having your distributor represent you in front of the Competent Authorities? The Competent Authority is the equivalent to the FDA in the USA. • If the Competent Authorities question an accident or a non-compliance that occurred in the distribution system will your distributor defend his company or yours? • If your distributor is unable to answer the Competent Authority’s questions does anyone in your company have the knowledge to do so directly? • Are you comfortable placing a
