Introduction: Why FDA Registration Matters
If you’re planning to import, manufacture, or sell food, cosmetics, supplements, or medical devices in Thailand, FDA registration is not just a legal requirement — it’s a business essential. This article covers everything you need to know about FDA registration in Thailand, who must register, what the process involves, and how to avoid common mistakes.
What Is the Thai FDA?
The Thai FDA (สำนักงานคณะกรรมการอาหารและยา) is a government agency under the Ministry of Public Health. Its mission is to protect public health by regulating the safety, quality, labeling, and marketing of consumer products that people consume or apply to their bodies.
Products That Require Thai FDA Registration
Before launching your product in Thailand, check whether it falls into one of these categories regulated by the Thai FDA:
Product Category | Examples |
🥫 Food & Beverages | Snacks, sauces, drinks, packaged meals |
💊 Drugs & Pharmaceuticals | Over-the-counter and prescription medications |
🧴 Cosmetics | Skincare, makeup, perfumes, personal care items |
🌿 Dietary Supplements | Vitamins, herbal extracts, weight-loss supplements |
💉 Medical Devices | Thermometers, COVID test kits, surgical tools |
☠️ Hazardous Substances | Household cleaners, pesticides, chemicals for consumer use |
Who Needs to Register with the Thai FDA?
If you are:
- A manufacturer of any regulated products in Thailand
- An importer bringing products into Thailand for sale
- A distributor or brand owner of cosmetics, food, or supplements
- A foreign company exporting products into the Thai market
Step-by-Step Thai FDA Registration Process
1. Company Registration
Your company must be legally established in Thailand or work with a licensed local representative.
2. Product Classification
Products are classified as:
- Controlled
- Notified
- Licensed
Each classification has different requirements.
3. Prepare Documentation
Common documents include:
- Product formula or ingredients list
- Labels in Thai language
- Certificate of Free Sale (for imported goods)
- GMP or ISO certification (for manufacturers)
4. Submission to Thai FDA
File your application through the FDA e-submission portal or in person, depending on the product type.
5. Inspection or Sampling (if applicable)
The FDA may conduct a site visit or request lab testing.
6. Approval & License Issued
If all is in order, you’ll receive an FDA product license or registration number, which must appear on packaging and marketing materials.
How Long Does FDA Registration Take?
- Cosmetics: 7–15 working days
- Supplements & Food: 1–3 months
- Medical Devices & Drugs: 3–6 months or more
⏳ Timelines vary depending on product risk, documentation quality, and responsiveness.
Common Mistakes to Avoid
- Using non-compliant packaging or Thai labels
- Skipping formula translation or ingredient certification
- Assuming your product is “safe enough” without registration
- Failing to appoint a local representative (for foreign brands)
📞 Need Help with Thai FDA Registration?
At Act and Align Advisor, we simplify the FDA registration process so you can focus on launching your brand.
👉 Whether you’re a startup or an international exporter — we help you get it right the first time.
📩 Contact us today to start your Thai FDA registration with confidence!
