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並前往https://www.asiaactual.com/wp-content/uploads/2017/07/FDA-Circular-No.-2017-003-Strict-LTO-Implementation.pdf

FDA Circular 2017-003 (Strict LTO requirements) - Asia Actual

Industries which manufacture, import and distribute medical devices that are registrable are required to secure LTO as Medical Device. Manufacturer, Importer ...

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