Thai FDA License Application Process

The Thai Food and Drug Administration (FDA) is responsible for the protection of consumer’s health and safety. They ensure the quality and efficacy of health products. The FDA regulates both manufactured or imported products. Thai FDA approval is required in order to manufacture or import products such as:

  • Food
  • Drugs
  • Psychotropic Substances
  • Medical Devices
  • Narcotics
  • Volatile Substances
  • Cosmetics
  • Hazardous Materials and Substances

The Thai FDA approval is based upon five different steps:

  1. Pre-marketing approval of the factory, product and advertising
  2. Post-marketing control: regular checks of the previously licensed facilities and products
  3. Surveillance program for consumers’ safety once the product has been launched (e.g. verify whether or not there are any side effects)
  4. Consumer protection and education to verify the accuracy and sufficiency of information given to the consumer
  5. Technical support and cooperation with other agencies (e.g. seminars organized or attended to by the FDA)

What we help you to achieve

Thai FDA dealing with various types of products, therefore  the application and certification processes are very different for each group. The amount of time that will pass by before you receive the approval of the FDA highly depends on the product that you are trying to get imported or manufactured. In any case, if the license is approved it will remain valid for three years

Pro License Co. Ltd. will assist you with 2 main steps of your product certification:

  1. Approval of the manufacturing facilities
  2. Approval of the product itself

There are many different parts of the FDA approval process and we will make sure you submit correct forms and prepare your manufacturing environment for the FDA inspection. We will work closely with your marketing group to develop FDA compliant product labels and packaging, arrange all necessary translation of printed materials.

Just to show how complicated Thai FDA application process is, please see the list of requirements and documentation:

1. Product information:

  • Trading name
  • Description of the type and characteristic of the product
  • Composition of raw material
  • Intended use of the product
  • Packaging
  • Chemical characteristic related to the quality or standard of ingredients by percentage of weight including type and quantity, microbiological characteristics
  • Shelf life
  • Name and address of production facility

2. Production Process Flow Chart

  • Specify the production steps
  • Specify temperature, time, pressure and method in the process
  • Specify the critical control point (CCP)

3. Certificate of Formula (COF):

  • Release date
  • Trading name and the type
  • The components (by percentage of each component)
  • Name, position, qualification and signature of the responsible person

4. Certificate of Analysis (COA) (Provide the details of chemical analysis result (ex. Antioxidant, BHA, BHT)):

  • Trading name and the type of the product
  • Name and address of manufacturer, consignor and consignee
  • Analytical date
  • Name and address of laboratory that analyzed the sample
  • Analytical methods, chemical and micro biological analysis result
  • Name, position, qualification and signature of responsible person in this laboratory

5. Sample of the product

6. FDA Certification from origin country

7. Certification of Origin

8. Certificate of free sale

Certain groups of products could be certified under provincial jurisdiction, but some are dome only on federal level. It is important to know the best and quickest path to your product certification. We will help you to achieve your goal in time and with the minimum expenses.

You can search which license you need here. If you cannot find appropriate license here, please contact us and we will provide you with free consultation and help you determine which Thai FDA license you need.

Thai FDA Product License Search, find out which license you need

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