A U.S. Authorized Representative plays a crucial role for foreign manufacturers seeking to market medical devices or other regulated products in the United States. Their primary responsibilities include:

1. Compliance Oversight: They ensure that the manufacturer's products comply with FDA regulations and standards. This includes facilitating the preparation and submission of required documentation, such as 510(k) premarket notifications or PMA (Premarket Approval) applications.

2. Communication Liaison: They act as the primary point of contact between the FDA and the foreign manufacturer. This role involves handling inquiries, notifications, and responses to regulatory issues or requests from the FDA.

3. Regulatory Submissions: The representative assists in the submission of required reports, such as adverse event reports or product changes, to the FDA. They also ensure that any necessary documentation, including labels and instructions, meet FDA requirements.

4. Support in Regulatory Matters: They help manage regulatory compliance issues, including product recalls or corrective actions. In case of compliance issues or inspections, the authorized representative acts on behalf of the manufacturer to address any findings or concerns raised by the FDA.

5. Record Keeping: They maintain accurate records of all correspondence, submissions, and communications with the FDA. This includes ensuring that all required documentation is kept up to date and readily accessible.

6. Market Surveillance: They may assist in monitoring the product’s performance in the U.S. market, ensuring that any safety concerns or reports of adverse events are addressed promptly.

Overall, the U.S. Authorized Representative plays a pivotal role in navigating the complex regulatory landscape of the FDA, ensuring that foreign manufacturers can successfully enter and maintain their presence in the U.S. market.

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