Fast & Hassle-Free Thai FDA Cosmetic Registration
We handle everything from formula checks to final FDA notification.
Your one-stop gateway to the Thailand beauty market.
Why Entering Thailand is Hard (And How We Make It Easy)
Your Challenges
1. Language barriers with Thai FDA.
2. Risk of banned ingredients.
3. No legal local entity to hold the license.
Our Solutions
1. Native experts handle all communications.
2. Pre-submission formula audit to guarantee approval.
3. We act as your authorized Local Agent.
Steps to Achieve Compliance
Step 1: Appoint a Qualified Local Agent (Key Prerequisite for Compliance)
A qualified Thai local responsible entity (Notifying Party) must be designated. According to the Cosmetic Act B.E. 2558 (2015) and its revision, foreign companies cannot directly register cosmetics in Thailand and must appoint a legally registered Thai entity as the Notifying Party.
The company must be legally registered with the Thai Ministry of Commerce and possess the necessary registration documents.
Choose a company with no serious violation records to minimize compliance risks.
If foreign investment is involved, it must comply with the Foreign Business Act requirements.
Import locations must meet Ministry of Public Health requirements (e.g., storage, ventilation, safety) and provide necessary facility information during registration.
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Step 2: Apply for a Thai FDA Cosmetic Registration Account (Access to the Compliance System)
Once the local responsible party is confirmed, they must apply for a cosmetic registration account with the Thai FDA. Required documents generally include:
Registration documents of the Thai local company (e.g., DBD certificate) and proof of legal representative identity.
Authorization letter and business license copy of the foreign company.
Address and supporting documents of the import warehouse (e.g., lease contract, photos), ensuring that the warehouse complies with Ministry of Public Health requirements.
Note: Some document requirements may vary depending on the product category or TFDA review.
Step 3: Pre-Compliance Review of Products (Avoid Registration Rejection and Compliance Risks)
Before preparing the full registration dossier, a pre-compliance review should be conducted to check whether ingredients, labels, and claims comply with regulations:
Ingredient compliance: Ensure prohibited substances are not used; restricted substances meet concentration limits (e.g., Phenoxyethanol ≤1%).
Label compliance: Labels must meet Thai FDA requirements, include Thai language, and clearly display product name, ingredient list, batch number, manufacture date, expiry date (if applicable), and importer information.
Claim compliance: Do not use medical claims or absolute terms (e.g., “cures acne,” “100% whitening”). Functional claims must be supported by data, literature, or other scientific evidence.
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Step 4: Prepare the Complete Registration Dossier (Ensure Compliance with FDA Submission Standards)
After passing the pre-compliance review, organize the full registration dossier according to TFDA requirements. The completeness and accuracy of documents directly affect registration efficiency. Key components include:
Cosmetic Registration Application Form: Complete the form with product names in Thai (English optional), consistent with labels. Product category must follow TFDA classification standards. Ingredient lists should be in INCI names or TFDA-approved names, with concentration percentages.
Authorization Letter: Within the valid period, clearly stating the scope and authority; granted by brand owner or manufacturer to the legally registered Thai entity.
Product Labels (English version, inner and outer packaging): 3D images showing brand and all readable label information.
GMP Certificates (e.g., ISO 22716): International standard certificates showing manufacturer, certification scope, issuing authority, and validity, supporting compliance with good manufacturing practices.
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Step 5: Submit Registration Documents to Thai FDA (Official Registration Stage)
Once all materials are prepared, submit the electronic dossier via the registration account:
Submit the cosmetic registration application.
The system checks document completeness; incomplete applications will be returned with reasons.
If complete, the system generates a Notification Receipt immediately.
TFDA may conduct manual checks or post-audit inspections; non-compliance may result in registration revocation under relevant provisions (e.g., Section 36 of the Cosmetic Act).
Registration timeline depends on document completeness and product category, generally completed quickly, with special cases taking longer (usually 15–20 working days).
Step 6: Prepare the Product Information File (PIF) for Record-Keeping (Ensure Ongoing Compliance)
After registration, companies must prepare a Product Information File (PIF) for TFDA inspections, as required by the Cosmetic Act and registration standards. Core contents include:
Administrative Documents and Product Overview: Registration-related files and basic product information.
Ingredient Quality and Safety Data: Documentation of ingredient quality and safety (e.g., supplier CoA, MSDS, or other references).
Product Quality and Safety Data: Including formulation, manufacturing process, and finished product test reports (e.g., microbiology, heavy metals, stability).
Cosmetic Safety and Efficacy Data: Safety assessment records, adverse reaction reports, and supporting evidence for functional claims (e.g., test data, literature). Also, retain label samples (inner and outer packaging).
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Why Choose Us
Discover the reasons that set us apart.
01
Professional Facilities
Warehouse and office fully compliant with Thai FDA requirements.
02
Expertise
Toxicology Experts Providing Professional Safety Assessments.
03
Multilingual
Efficient Communication with Full Chinese Language Support.
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