Foreign Drug and Device Manufacturer Registration in US
New rules require foreign companies manufacturing drugs or medical devices to register with the U.S. Food and Drug Administration (FDA), even if their products undergo further processing outside the U.S. before import. This aims to enhance the safety and quality of medical products available to citizens.
Key points
All foreign establishments manufacturing drugs or medical devices for the U.S. market must register with the FDA.
Registration is required even if products are further processed outside the U.S. before being imported.
These changes aim for better control over imported medical products, potentially leading to increased patient safety.
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