Do you need to import food supplements, pharmaceuticals, and products for animal health, toxic substances, narcotic, and food in Thailand? Then you will require registering with the Food and Drug Administration of Thailand (FDA). However, the time needed for filing a product registration application and receiving registration certificates with the FDA varies hugely. Approximate time taken is mentioned below;
- General medical devices and toxic substances: one month to four months;
- Cosmetics: one week;
- Food products and pharmaceuticals: a couple of months (approx.);
Drug Registration in Thailand
The FDA in Thailand needs importers and manufacturers to get FDA approval prior to manufacturing or importing. However, the FDA categorizes drugs into traditional medicines, veterinary medicines, modern, and generic medicines, each with separate registration requirements. On the other hand, generic medicines are classified into different categories, including new medicines, new generics, and generic medicines.
Medical Device Registration in Thailand
The medical devices are regulated by a specialized division in FDA Thailand. They either require licensing or registration. However, the Thai FDA medical devices groups are further divided 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;
Hazardous Substances Registration
Thai FDA categorizes hazardous substances into four types mentioned below;
- “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 the wellbeing of consumers, animals, plants, property, or the environment. Thai law prohibits the importation, exportation, and possession of Type 4 substances in Thailand.”
