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Thailand FDA Registration

Background

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).

Thailand Drug Registration

The Thai FDA requires importers and manufacturers in Thailand to obtain FDA approval prior to importing or manufacturing drugs or medicines in Thailand. 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 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:

  1. Class 1 medical devices: condoms, surgical gloves, syringes, and diagnostic test kits.
  2. 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.
  3. Class 3 medical devices: lowest-risk devices category.

Thailand Cosmetics Registration

The Thai FDA requires importers and manufacturers in Thailand to obtain FDA approval prior to importing or manufacturing drugs or medicines in Thailand. 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 Drug 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:

  1. 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.
  2. 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.
  1. 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.
  2. 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. 

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.

Our Experience

Chaninat and Leeds' attorneys and legal staff have assisted clients in registering pharmaceuticals, food supplements, medical devices, and cosmetics with the Thailand Food and Drug Administration. Our clients are normally foreign companies with local Thai branches or companies. In several of our cases, many of the drug and supplement registrations are for new products that may be popular abroad but have not yet entered the Thailand market. Similarly, we have assisted the registration of Thai medical devices developed with the technologies abroad.

Related Video:

Thailand FDA Application Process