An Authorized Representative plays a vital role in the regulatory process for medical devices, serving as a liaison between manufacturers and regulatory authorities. In the EU, an Authorized Representative is required for non-EU manufacturers to market their products within the EU and EEA. Similarly, for manufacturers outside the US, a US Agent fulfills a similar function in liaising with the US Food and Drug Administration (FDA).

The responsibilities of an Authorized Representative or US Agent include:

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     Regulatory Compliance: Ensuring that medical devices meet regulatory requirements in their respective regions. 
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      Communication: Facilitating communication between manufacturers, regulatory authorities, and other stakeholders.
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      Documentation: Assisting with the preparation and submission of regulatory documentation.
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     Post-Market Surveillance: Supporting post-market surveillance activities and reporting as required.
•     Choosing a reliable Authorized Representative or US Agent is crucial for navigating complex regulatory landscapes and ensuring compliance with relevant regulations.