Certification of goods in Thailand
FDA Product Registration in Thailand
Our company provides a full range of services for the registration and certification of imported goods, including document preparation and company registration with the relevant government departments. Registration is required for pharmaceutical products, medical devices, food products, dietary supplements, veterinary health products, animal feed, and other medical, pharmaceutical, and hazardous substances in Thailand.
Download Thailand FDA Certificate
The time required to register a product and obtain FDA registration certificates in Thailand can vary significantly. Estimated registration times: cosmetics — 1 to 2 weeks; general pharmaceuticals and hazardous substances — 1 to 4 months; food products — from 1 week.
Registration of Pharmaceuticals in Thailand
FDA registration in Thailand is mandatory for both importers and manufacturers. FDA approval must be obtained before import or production begins. The Thai FDA classifies pharmaceuticals into modern, general, traditional, and veterinary medicines — each with its own set of registration requirements. General medicines are grouped into generic drugs, new drugs, and new generics, each requiring separate documentation.
Registration of Medical Devices in Thailand
Medical devices in Thailand are regulated by a specialized FDA division. Devices require either a license or registration. The Thai FDA classifies medical devices into 3 classes:
Class 1 Medical Devices: Condoms, surgical gloves, syringes, and diagnostic test kits.
Class 2 Medical Devices: Rehabilitation equipment, blood alcohol test kits, silicone implants, and other diagnostic tools. Class 2 devices require a USFDA certificate.
Class 3 Medical Devices: Devices with the lowest risk category.
Cosmetic Registration in Thailand
The Thai FDA classifies cosmetics into two categories based on ingredients:
1. Standard Controlled Cosmetics: Products without regulated ingredients require an FDA product notification before market launch. This process is usually completed within 1 day.
2. Specially Controlled Cosmetics: Products containing regulated substances require full registration, typically taking up to 30 working days.
Cosmetics without regulated ingredients are currently categorized as general cosmetics.
Hazardous Substances Registration
Under Thailand’s Hazardous Substance Act, the Thai FDA classifies hazardous substances into four types based on their level of danger:
**Type 1 Hazardous Substances:** Low-risk products that require monitoring. Import, export, production, or storage of Type 1 substances does not require licensing or registration, but must comply with specific criteria.
**Type 2 Hazardous Substances:** Products requiring regulation and monitoring. Type 2 requires FDA product notification, registration, and compliance with criteria.
**Type 3 Hazardous Substances:** Higher-risk products that require strict control procedures. Type 3 substances must obtain FDA permission and a registration certificate.
**Type 4 Hazardous Substances:** Products that may endanger consumer health, animals, plants, property, or the environment. Thai law prohibits the import, export, or possession of Type 4 substances.
Food Product Registration in Thailand
Imported controlled food products must be registered with the Thai FDA and translated into English. Each product must be analyzed, including ingredients and processing details. Thai FDA standards must also be approved for individual manufacturing licenses. Import licenses must be renewed every 3 years.
Obtaining Thai FDA Licenses
Obtaining a license to import or produce food or pharmaceutical products in Thailand involves extensive documentation. Registration certificates and supporting documents from other jurisdictions are required during the FDA registration process. All applications are processed by licensed FDA attorneys after obtaining necessary testing results.
Cost of FDA Registration in Thailand
The cost of FDA registration in Thailand depends on the type of product. To calculate the exact cost, please contact our specialists. You will need to provide existing certificates and documents, product samples (we can assist with delivery if needed), manufacturer information, and other required documentation. Our company has extensive experience with product registration and licensing. Contact us today!