Thai FDA registration
THAI FDA REGISTRATION
Thai FDA registration is necessary for every import of medical devices, pharmaceuticals, food, food supplements, products for animal health, or other medical, narcotic and toxic substances.Introduction into Thailand requires registration with the Food and Drug Administration of Thailand (FDA). The time and documentation required for getting a License in Thailand and receiving registration certificates with the FDA can vary widely.
A basic rule is that only a Thai registered entity can be holder of a FDA License. Thus, a foreign manufacturer needs necessarily a local Distributor or License Holder.
Drug Registration in Thailand
The Thai FDA requires Thai importers and manufacturers to obtain FDA approval before importing or manufacturing drugs or medicines in Thailand. Thai FDA categorizes drugs into modern, general medicines, traditional medicines and veterinary medicines, each having separate requirements. General medicines are grouped into separate categories of generic medicines, new medicines and new generics, each with different requirements.
Medical Devices Registration in Thailand
Medical devices in Thailand are regulated by a separate division in the Thai FDA. The FDA groups Medical devices into 3 classes or sub-categories as follows:
- condoms, surgical gloves, syringes and diagnostic test kits.
- rehabilitation devices, blood alcohol level measuring kits, silicone implants, and test kits other that for diagnostic purposes. Class 2 requires a USFDA certificate.
- all medical devices not listed in first two categories.
Time for registration is variable from 2 weeks to 6/8 months. Before registering ht e Medical Device, the business place of License Holder must be approved/updated..
Registration of Cosmetics in thailand
Thai FDA registration for cosmetics was in the past set into two categories according to the ingredients content of the cosmetics:
- Controlled Cosmetics
- Specially Controlled Cosmetics
Nowadays, system has changed. All Cosmetics have the same procedure, that is normally completed in one working week in straightforward cases. A special file containing all the products data (named PIF; PIF must be kept into Distributor’s business place).
Hazardous Substances Registration
Pursuant to the Hazardous Substance Act of Thailand, the Thai FDA classifies hazardous substances into four types according to degree of Type hazard:
- 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.
- 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.
- hazardous substances: Products with a greater degree of hazard require a stricter control procedure. Type 3 must obtain FDA permit and registration certificate.
- hazardous substances: Products that may endanger well-being of consumers, animals, plants, property or the environment. Thai law prohibits the importation, exportation and possession of Type 4 in Thailand.
Food Registration in Thailand
Food products imported into Thailand must previously be registered with the Thai FDA with labels fully translated in Thai language. The product must be analyzed, including the details of processing and ingredients to ensure meeting Thai FDA standards. A separate manufacturing license must also be obtained. Import licenses must be renewed every 3 years.
Our model starts with THAI FDA Registration
THAI FDA REGISTRATION
When you import your products in Thailand we act this way:
Pre-check in Thai FDA: verification of certifiability of your products/medical devices; Control of your communication, labels, visuals; request for documentation for obtaining FDA license.
Market pre-check: we analyze the potential of your product, introduce it to our distributor network and KOL in hospitals. We analyse the competitors and focus on your competitive advantages. prepare a report wich will indicate you the right approach to market and strategy in commercial and pricing.
Thai FDA Registration: once received and verified your documents, we proceed in getting your license in Thai FDA. You will be indicated as Manufacturer, Kha Group will be indicated as Importer.
If you want to assign the license to a third party, we will do it.
The product is provided in Joint Venture with KHA GROUP