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How Do Authorized Representatives Contribute to Medical Device Registration and Market Access?
Category：行業(yè)資訊 Date：2024-09-13 17:25:55 Author: Source:
Additionally, ARs are instrumental in ensuring that all regulatory documentation is accurate and up-to-date, which helps in mitigating potential issues with FDA compliance. However, manufacturers must stay engaged in ongoing regulatory activities and address any emerging issues directly to maintain compliance and ensure market success

In the U.S., Authorized Representatives (ARs) are not responsible for handling all issues related to medical devices on behalf of manufacturers. Their primary role is to serve as a liaison between the manufacturer and the U.S. Food and Drug Administration (FDA). This includes ensuring that the manufacturer's device complies with FDA regulations, facilitating the submission of required documents, and addressing regulatory inquiries.7(3).jpg

While ARs assist with the initial registration and regulatory submissions, they do not manage all operational aspects. Manufacturers retain responsibility for day-to-day issues such as product quality, adverse event reporting, and compliance with post-market requirements. ARs can support manufacturers by helping navigate regulatory challenges, but they do not replace the manufacturer's obligation to manage and monitor their product in the U.S. market.

Additionally, ARs are instrumental in ensuring that all regulatory documentation is accurate and up-to-date, which helps in mitigating potential issues with FDA compliance. However, manufacturers must stay engaged in ongoing regulatory activities and address any emerging issues directly to maintain compliance and ensure market success

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