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Importing pharmaceuticals, food, food supplements, products for animal health, medical devices,
cosmetics, or other medical and hazardous substances into Thailand requires registration with
the Food and Drug Administration of Thailand (FDA).
FDA requires importers and manufacturers in Thailand to obtain FDA approval prior to
importing or manufacturing drugs or medicines to the country. The FDA categorizes drugs by modern,
general medicines, traditional medicines, and veterinary medicines. Each category has separate
registration requirements. General medicines are grouped into separate categories: generic medicines,
new medicines, and new generics. Each medicine category also has a distinct set of registration requirements.
Thailand Food Registration
Importing controlled food products into Thailand requires registration with the Thai FDA and labels
must be fully translated into the Thai language. The food must be analyzed, including the details
of processing and the ingredients to meet Thai FDA standards; a separate manufacturing license
must also be approved. Import licenses must be renewed every 3 years.
For more information: Food Division
https://www.fda.moph.go.th/sites/FDA_EN/SitePages/Food.aspx?IDitem=Overview
List of Registered Certifying Bodies
https://www.fda.moph.go.th/sites/food/SitePages/Unit.aspx
Thailand Medical Devices Registration
Medical devices are regulated by a specialized division in the Thai FDA. Medical devices require either licensing
or registration. The Thai FDA groups medical devices into 3 classes:
Class 1 medical devices: condoms, surgical gloves, syringes, and diagnostic test kits.
Class 2 medical devices: rehabilitation devices, blood alcohol level measuring kits,
silicone implants, and test kits other than for diagnostic purposes. Class 2
requires a USFDA certificate.
Class 3 medical devices: lowest-risk devices category.
Thailand Cosmetics Registration
The Thai FDA classifies cosmetics into two categories based on the ingredients composition of the cosmetics:
1. Controlled cosmetics: Cosmetic products made of controlled ingredients will require product notification
to the FDA before products are allowed to be released on the market. The notification process is normally
completed in one day.
2. Specially controlled cosmetics: Cosmetics made with specially controlled ingredients require registration,
which generally takes 30 working days.
Cosmetics containing no controlled or specially controlled ingredients are currently classified as general cosmetics.
Hazardous Substances Registration
Pursuant to the Hazardous Substance Act of Thailand, the Thai FDA classifies hazardous substances into
four types according to degree of hazard:
Type 1 hazardous substances: Products with a low degree of hazard that need to be monitored.
Importation, exportation, manufacturing or possession of a Type 1 substance in Thailand does not
require licensing or registration but specific criteria and procedures must still be met.
Type 2 hazardous substances: Products that need to be both monitored and controlled.
Type 2 requires product notification to the FDA, registration, and compliance to specific criteria.
Type 3 hazardous substances: Products with a greater degree of hazard require a stricter control procedure.
Type 3 must obtain an FDA permit and registration certificate.
Type 4 hazardous substances: Products that may endanger wellbeing of consumers, animals, plants, property,
or the environment. Thai law prohibits the importation, exportation, and possession of Type 4 substances
in Thailand.
Source: Food and Drug Administration
