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Can a distributor apply for FDA registration in the United States?
Category：行業(yè)資訊 Date：2024-11-12 17:01:03 Author: Source:
In the United States, a distributor typically cannot apply for FDA registration on behalf of a manufacturer. FDA registration is generally required for the manufacturer or the initial distributor of a medical device. This means that the entity that is responsible for manufacturing, labeling, or importing the device into the U.S. must complete the registration process.

In the United States, a distributor typically cannot apply for FDA registration on behalf of a manufacturer. FDA registration is generally required for the manufacturer or the initial distributor of a medical device. This means that the entity that is responsible for manufacturing, labeling, or importing the device into the U.S. must complete the registration process.2(2).jpg

However, if the distributor is importing devices, they may need to register with the FDA as an importer or foreign manufacturer representative. They would also need to ensure that the products comply with FDA regulations. But the actual registration and listing of the device must be completed by the manufacturer or the U.S. agent (if the manufacturer is foreign).

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