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What is a U.S. Medical Device Local Authorized Representative?
Category：企業(yè)動(dòng)態(tài) Date：2024-12-24 17:08:22 Author: Source:
A U.S. Medical Device Local Authorized Representative (LAR) is a person or entity based in the United States that is authorized by a foreign medical device manufacturer to act on its behalf for regulatory purposes. The LAR serves as a liaison between the manufacturer and the U.S. Food and Drug Administration (FDA), and may also represent the manufacturer in communication with other authorities or stakeholders within the U.S. healthcare system.

A U.S. Medical Device Local Authorized Representative (LAR) is a person or entity based in the United States that is authorized by a foreign medical device manufacturer to act on its behalf for regulatory purposes. The LAR serves as a liaison between the manufacturer and the U.S. Food and Drug Administration (FDA), and may also represent the manufacturer in communication with other authorities or stakeholders within the U.S. healthcare system.

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Key responsibilities of a U.S. Local Authorized Representative include:

  1. Regulatory Communication: The LAR acts as a point of contact for the FDA and other U.S. authorities, ensuring that the manufacturer complies with FDA regulations, including device registration, listing, and post-market surveillance requirements.

  2. Compliance Assistance: The LAR helps ensure that the manufacturer's devices meet FDA standards, including those related to labeling, manufacturing, and quality control.

  3. Representation: If the manufacturer is not located in the U.S., the LAR must be based in the country and is legally authorized to represent the manufacturer in the U.S. The LAR's contact information will be included in the FDA’s registration database.

  4. Importation and Distribution: The LAR may also handle matters related to the importation of medical devices into the U.S., including dealing with customs procedures and ensuring that products are not distributed in the U.S. until they are compliant with FDA regulations.

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