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Is a Certificate of Origin Required for U.S. Medical Device Certification?
Category：行業(yè)資訊 Date：2024-09-10 17:07:52 Author: Source:
?No, a Certificate of Origin is generally not required for U.S. medical device certification. The FDA focuses on the device's safety, effectiveness, and regulatory compliance rather than the origin of the product. However, documentation related to the manufacturing process, quality management, and device specifications is crucial for the certification process. If the device is imported, customs and import regulations might require information about the origin, but this is separate from the FDA’s certification requirements.

No, a Certificate of Origin is generally not required for U.S. medical device certification. The FDA focuses on the device's safety, effectiveness, and regulatory compliance rather than the origin of the product. However, documentation related to the manufacturing process, quality management, and device specifications is crucial for the certification process. If the device is imported, customs and import regulations might require information about the origin, but this is separate from the FDA’s certification requirements.7(4).jpg

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