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What are the FDA registration requirements for export?
Category：行業(yè)資訊 Date：2024-08-06 16:49:07 Author: Source:
By meeting these requirements, manufacturers can ensure that their devices are eligible for export to the U.S. market and are compliant with FDA regulations.

The FDA registration requirements for exporting medical devices to the U.S. involve several key steps and considerations:

  1. Establishment Registration: Foreign manufacturers, as well as domestic ones, must register their establishments with the FDA. This registration is required for all companies involved in the production, preparation, propagation, or processing of medical devices intended for the U.S. market. This process ensures that the FDA is aware of the entities involved in device manufacturing.

  2. Device Listing: In addition to establishment registration, manufacturers must list each device they intend to export. This device listing includes details about the device, such as its intended use, classification, and labeling.

  3. Premarket Submission:

    510(k) Notification: For many Class I and II devices, a premarket notification (510(k)) must be submitted to demonstrate that the device is substantially equivalent to a legally marketed device.Premarket Approval (PMA): For Class III devices, a PMA application is required, which involves comprehensive clinical data to establish safety and efficacy.De Novo Classification: For devices that do not fit existing classifications, a De Novo request may be needed to create a new classification.

  4. Compliance with U.S. Regulations: Devices must comply with FDA regulations, including labeling requirements, quality system regulations (QSR), and other applicable standards. This ensures that devices meet safety and effectiveness criteria before entering the U.S. market.

  5. Import Requirements: Devices imported into the U.S. must comply with U.S. Customs and Border Protection (CBP) regulations. This includes proper documentation, such as a valid FDA registration and device listing, to clear customs.

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