The timeline for FDA registration for export can vary depending on several factors:

1. Submission Completeness: The initial submission of FDA registration documents must be complete and accurate. Any deficiencies or missing information can delay the process.

2. FDA Review Process: After submission, the FDA conducts a review to ensure compliance with regulatory requirements. This review process typically takes several weeks to months, depending on the complexity of the device and the completeness of the submission.

3. Additional Information Requests: During the review, the FDA may request additional information or clarification on certain aspects of the submission. Responding to these requests promptly can affect the overall timeline.

4. Inspections: For certain devices, FDA may conduct facility inspections to verify compliance with Quality System Regulation (QSR) requirements. The scheduling and completion of inspections can add additional time to the registration process.

5. Approval and Issuance: Upon successful review and any necessary inspections, the FDA will issue an Establishment Registration Number. This number is required for exporting medical devices to the United States market.

6. Ongoing Compliance: Post-registration, maintaining compliance with FDA regulations, including annual registration renewal and reporting requirements, is essential for continued export.

In general, the timeline for FDA registration for export can range from several months to over a year, depending on the specific circumstances of the device and the efficiency of the submission process. Early preparation, thorough documentation, and proactive engagement with regulatory requirements can help streamline the timeline for FDA registration for export.

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