FDA License


A FDA license is required to import foods, drugs, cosmetics, psychotropic substances, narcotics, medical devices, volatile substances and hazardous substances to Thailand.  

The procedure to obtain a Thailand FDA license requires inspection of the business premises of the importer.  

The Thailand FDA has very subjective requirements depending on the intended business activities and will not approve all business premises.

For example, some business premises may be considered too small for the intended business activities by the Thailand FDA.

The Thailand FDA can also demand for a business to install specific types of equipment or fixtures prior to approving a license.

We highly recommend consulting with the Thailand FDA in person prior to obtaining a business premises.

Our FDA license application service includes the following:

  • Prepare a FDA license application with the assistance of the client providing all required information and documents.
  • Filing the application with the FDA.
  • Assist in communicating with the FDA.
  • Accompanying the representatives of the client in meetings with the FDA.
  • Follow up the application with the FDA.
  • Submit any additional information or documents required by the FDA with the assistance of the client.
  • Receive the FDA license.
  • Provide an English translation of the FDA license.
  • Correspondence by email, telephone and in person meetings when necessary.