Attention Taiwan companies that regularly export medical devices to the U.S.! FDA Agent Selection Key Guidelines

Taiwanese companies that routinely export medical devices to the United States should take note! The U.S. Food and Drug Administration (FDA) specifically requires that any foreign organization involved in the manufacture, preparation, propagation, synthesis, or processing of medical devices imported into the U.S. must designate a U.S. agent for that organization. This is not an optional but a mandatory requirement!

Can you believe it? Many Taiwan cross-border sellers and medical device manufacturers have been unable to enter the U.S. market or even face regulatory risks because they were unaware of this requirement or chose an unqualified agent.FDA U.S. agents must be U.S. residents or have a place of business in the U.S., and may not use a P.O. Box as an address or a telephone answering service only.

Instead of taking the risk of choosing an unprofessional agent, you should choose a professional organization with 25 years of experience like MDSS, who, as an authorized representative of European medical device, IVD, and cosmetic manufacturers, has the experience, knowledge, and drive to ensure that as your U.S. agent, you will be guided to success in the United States.

What's more, MDSS' U.S. office is fully equipped to handle all of your U.S. FDA needs with the same efficiency, confidentiality and speed as its offices in Europe, the U.K. and Switzerland. This is a convenient one-stop shop for cross-border brand owners who need global compliance support.

Particular attention needs to be paid to the allocation of responsibilities between the U.S. agent and the foreign agency:

The U.S. Agent is responsible:

• Maintaining a physical office presence in the United States
• Provide updates on organization registration and product listings
• Responsible for providing communication between the FDA and the company

Foreign organizations are responsible:

• Provide updates on changes to its U.S. agency registration
• Notify its agents of new products or changes to currently listed products.
• notify its agent of any changes in contact details

It's not just the formality of having a U.S. agent that really helps you achieve compliance, it's choosing a professional, reliable and experienced partner. Green Circle is just such a choice!

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#F U.S. Agents of the D.A. # Medical Device Exports # Taiwan Manufacturers # Cross-Border E-Commerce # Compliance # Risk Prevention # International Brands # Global Sales