To proceed with FDA registration, a Thai company must be established. This entity will be responsible for all regulatory filings related to importation and product registration.
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FDA Registration & Licensing in Thailand
Let our FDA expert team handle your FDA registration (Medicine, Food, Drug, Cosmetics, Medical Devices, Herbal Product, Hazardous Substance, Narcotic Drug & Psychotropic) in Thailand
Complete steps to start selling or distributing FDA controlled items in Thailand
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Step 1: Establishment of a Thai Business Entity
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Step 2: VAT Registration
Following company incorporation, VAT registration is required.
The following original documents must be submitted:
- PP01 — Application for VAT registration
- PP01.1 — Supplementary document for VAT registration
- PP20 — VAT registration certificate
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Step 3: Import & Export License for Food (Issued by FDA)
To legally import dietary supplements or food-related products, an Import & Export License and approval by the FDA department is required.
Key Requirements:
- Warehouse Registration: The company must register a warehouse facility. It is recommended that the warehouse be located in the same province as the registered business address to streamline the approval process.
- Site Inspection: The warehouse will be subject to inspection by FDA officers to verify compliance with regulatory standards.
- Thai Director Requirement: A Thai director is needed to sign documents (for administrative purposes only). If a company seal exists, it must also be provided.
Service Fee:
THB20,000
Issued to the company
Timeline:
Dependent on the queue at the FDA. Range from 2 months to 4 months.
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Step 4: Product Registration under Thai FDA
Once the Import & Export License is issued, each product must be individually tested & registered with the Thai FDA.
Processing Timeline & Requirements:
- If all documents are correct and complete, approval takes 30-45 working days.
- Any incorrect or missing documentation may result in delays or additional review periods.
Documents required for Product Registration with the Thai FDA. To ensure smooth FDA evaluation & approval, the following documents must be submitted:
- Company Documents (Company Affidavit, Business License)
- Product Formula & Specification Sheet
- Labeling & Packaging Design (must comply with Thai regulations)
- Certificate of Free Sale (CFS) from the country of origin
- GMP Certificate (Good Manufacturing Practice)
- Analysis Reports (Heavy Metals, Microbiological Tests)
Service Fee:
THB25,000
per product
Timeline:
30-45 working days
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Step 5: Thai Customs Registration (Import & Export License)
To import or export registered products, the company must be registered with Thai Customs. This step ensures that the company’s business activities align with FDA food registration requirements.
Service Fee:
THB45,000
Timeline:
3-5 working days
If all submitted documents are accurate.
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Step 6: Registration with the Department of Foreign Trade
Additionally, the company must be registered with the Department of Foreign Trade (DFT) comply with regulations related to food distribution and branding.
Service Fee:
THB20,000
Timeline:
3-5 working days
If all submitted documents are accurate.
Additional Notes:
- The warehouse address should be in the same province as the registered Company to facilitate an easier approval process.
- A Thai director is required for document signing, but this is purely administrative.
- The FDA processing time depends on application volume, and expedited registration is not available.
- All documents must be submitted accurately to prevent delays in the approval process.
We hope this proposal provides a clear overview for FDA Registration & Licensing in Thailand for Supplement Product. Please let us know if you require any further details or clarification. To get started, just let us know.
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