What is the FDA Import License and who needs to acquire it?

The Thailand FDA Import License is required for registering regulated goods that are being brought into the country from a foreign manufacturer with the intent of being distributed within the Thai market.

In order to apply for an FDA Import License, you must secure a Free Sale Certificate, as well as ensure that your goods meet customs clearance requirements:

📄 Free Sale Certificate details:

  • Manufacturer’s details
  • Authorized representative details (Non-EU manufacturers)
  • VAT Number
  • Applicable manufacturing certificates
  • Local Inspection report

⚠️ Requirements for customs clearance:

  • Commercial Invoice
  • Packing List
  • Bill of lading
  • Certificate of origin
  • Product specific licenses

Documents required for Import License application

Emerhub can assist in securing the necessary documents to ensure the application is complete and meets all requirements. Our advisors will also submit and manage the application process for you. We can also act as your consignee and provide logistical support through our Importer of Record service.

The following documents are required for a Thailand FDA Import License (can vary depending on industry/activity):

  • Application
  • Affidavit
  • Free Sale Certificate
  • VAT certificate
  • Seal of registration
  • Andi Ref - Emerhub Indonesia - Bali

    Andi Refandi

    Andi serves as a Senior Account Executive on Emerhub’s global team.