Thailand FDA Registration
Importing pharmaceuticals, food, food supplements, products for animal health, or other medical, narcotic and toxic substances into Thailand requires registration with the Food and Drug Administration of Thailand (FDA). The time required for filing product registration application in Thailand and receiving registration certificates with the FDA can vary widely. Approximate times for registration are as follows: cosmetics one week, general medical devices and toxic substances between one month to four months, whereas food products and pharmaceuticals can take several months.
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 into modern, general medicines, traditional medicines and veterinary medicines, each having a separate registration requirements. General medicines are grouped into separate categories of generic medicines, new medicines and new generics. Each category of medicines has a distinct set of requirements. The Thai FDA issues drug licenses for indefinite periods of time.
Thailand Medical Devices Registration
Medical devices in Thailand are regulated by a specialized division in the Thai FDA. Medical devices will require either licensing or registration. The Thai FDA groups medical devices into 3 classes' sub-categories as follows:
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 that 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 according to the ingredients content of the cosmetics:
- 1. Controlled Cosmetics: controlled ingredients content of a cosmetic product will require product notification to the FDA before it is allowed to be released onto the market. The notification process is normally completed in 1 one day.
- 2. Specially Controlled Cosmetics: if specially controlled ingredients are used in a cosmetic product this will require registration. The Registration process 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 will not require licensing or registration but are required to meet specific criteria and procedures.
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 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 in Thailand.
Thailand Food Registration
Importing controlled food products into Thailand must be registered with the Thai FDA with labels fully translated into the Thai language. The food must be analyzed, including the details of processing and ingredients to ensure meeting Thai FDA standards for a separate manufacturing license must also be approved. Import licenses must be renewed every 3 years.
Obtaining Thai FDA Licenses
Acquiring a license to import or manufacture food or drugs in Thailand requires a large amount of documentation. Registration certificates and supporting documents from other jurisdictions are useful in assembling a Thai FDA application. A complete and thoroughly reviewed application completed by a specialized Thailand FDA lawyer with all obtained documents can assist with expedition the filing process. FDA fees vary depending on the item being registered.