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Is Medical Device Certification in the United States Called FDA or KFDA?
Category：企業(yè)動(dòng)態(tài) Date：2024-12-12 17:17:30 Author: Source:
In the United States, medical device certification is overseen by the FDA (Food and Drug Administration), not KFDA. The KFDA (Korean Food and Drug Administration) is the regulatory authority for medical devices in South Korea. Therefore, when referring to medical device certification in the U.S., it is called FDA certification.

In the United States, medical device certification is overseen by the FDA (Food and Drug Administration), not KFDA. The KFDA (Korean Food and Drug Administration) is the regulatory authority for medical devices in South Korea. Therefore, when referring to medical device certification in the U.S., it is called FDA certification.

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