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No, a distributor cannot directly apply for FDA registration in the United States for a medical device. The FDA registration process primarily applies to manufacturers, initial distributors, and repackers. Here’s why:

1. Manufacturer Responsibility

• The primary responsibility for FDA registration lies with the manufacturer of the device. The manufacturer must register their establishment with the FDA and list the devices they produce.
• If the device is imported, the manufacturer or the U.S. importer (who is responsible for bringing the device into the U.S.) must ensure FDA compliance.

2. Distributor Role

• A distributor acts as an intermediary between the manufacturer and the end user (such as healthcare providers or hospitals). However, distributors typically do not register medical devices with the FDA, as they do not manufacture or label the devices.
• Distributors are not responsible for FDA registration or listing, but they must ensure that the devices they distribute are FDA-approved or cleared before they are marketed.

3. FDA Registration Requirements

• The FDA requires establishment registration for manufacturers, repackers, and relabelers. Distributors do not need to register with the FDA unless they are also acting as a manufacturer or importer.
• In the case of importers (including distributors who bring devices into the U.S. from abroad), they must ensure that the devices they import meet FDA requirements. An importer might need to assist the manufacturer with certain regulatory requirements but will not be the one to register the device.

4. U.S. Agent for Foreign Manufacturers

• If a foreign manufacturer does not have a presence in the U.S., they are required to designate a U.S. agent to act as the point of contact between the FDA and the manufacturer. Distributors can sometimes act as the U.S. agent, but they still do not register the device itself.

In summary, while a distributor may have responsibilities related to FDA compliance (such as ensuring the products they distribute are FDA-compliant), they are not the party that applies for FDA registration. The manufacturer or importer is typically responsible for the registration process.

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