Whenever you think of marketing your product in a different market like EU, UK, USA or global markets, if your company does not have a physical location, then you need an Authorized Representative who serves as a liaison between you and the National Health Authorities to comply to the Directives and Regulations. It is possible to nominate a distributor as your Authorized Representative; however, it is not advisable as most distributors are not equipped to execute the mandatory responsibilities of the Authorized Representative. To separate your commercial and regulatory interests, it is not a good idea to appoint a distributor as your Local Authorized Representative.
As your Local and Authorized Representative, we act as a link between you and the health authorities / notified bodies. As an independent organization, MakroCare can act as your regulatory guide and Authorized Representative to assist you to:
MakroCare developed this service over many years to specifically support the needs of small and medium-sized manufacturers
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