นำเข้าเครื่องมือแพทย์

The importation of medical devices must be conducted through the Food and Drug Administration (FDA). The main steps include:

1.Registering the importing establishment,

2.Registering the medical device (based on its risk classification),

3.Applying for an import license (License per Invoice – LPI), and

4.Completing customs clearance procedures and submitting required documents at the FDA checkpoint.

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All necessary documents must be properly prepared, such as product labels, product details, licenses, and a power of attorney (if applicable), to ensure legal compliance and allow the device to be imported for distribution or personal use.