Thailand Product Registration & Certification
Important Notes
- FDA Mandatory Product Registration & Licensing: All pharmaceuticals, medical devices, foods, cosmetics, and hazardous substances require approval and licenses from the Thai Food and Drug Administration.
- Clear Regulatory Framework for Dietary Supplements: Defined as Specifically Controlled Foods, they require product registration. Ingredients, claimed benefits, and advertising are pre-approved and strictly monitored.
- Local Authorized Representative or Agent Requirement: A foreign manufacturer must appoint a locally registered Thai company as the Authorized Representative for registration, import, and all official FDA communication.
- Absolute Thai Language Labeling Requirement: Key product label information must be in Thai. Registration documents submitted to Thai FDA also require Thai versions or certified translations.
- Price Control & Influence of Universal Health Coverage: Prices of some essential drugs and devices are controlled. The National Health Security Office’s reimbursement and procurement policies critically impact market access.
- Integrated Management of Traditional Thai Medicine & Modern Products: Herbal products based on Thai traditional medicine have a distinct registration pathway, reflecting the fusion of traditional knowledge and modern regulation.
Thailand Specific Requirements
- Hub for Medical Tourism & Wellness Industry in Southeast Asia: World-class medical services, competitive pricing, and a mature wellness tourism sector attract international patients and health consumers.
- Duality of Strict Regulation & Pro-Industry Development: The Thai FDA is known for strict enforcement, while the government actively supports bio-tech, medical device, and supplement manufacturing through industrial policies.
- Consumer Dual Affinity for Local Herbal Wisdom & International Brands: Consumers trust Thai herbal products and also pursue high-quality international brands, creating a diverse market.
- Highly Developed Digital Marketing & E-commerce Channels: Social media and e-commerce are vital for promoting and selling cosmetics, supplements, and OTC products, with influencer marketing being highly effective.
- Key Player in ASEAN Pharmaceutical Harmonization: Thailand is a core driver of the ASEAN harmonization scheme for pharmaceuticals and traditional medicines, making its domestic registration valuable for regional planning.
Medical Devices Registration
Regulatory Requirements
- Medical Device License
- Classification Management by Risk Level (Class 1, 2, 3)
- Complete Technical Documentation and Test Reports (Thai language)
- Quality Management System Certificate
- Thai Labeling and Instructions for Use
- Free Sale Certificate
- Product Technical File
- Clinical Data (if applicable)
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Representative Appointment
- Thailand FDA Application Submission
- Technical Review and Sample Testing
- License Acquisition
Registration Timeline
9-15 months
Official Fees
THB 80,000 - 800,000
Service Fees
$15,000 - $40,000
Regulatory System Overview
Thailand FDA
Thailand Food and Drug Administration
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, food supplements, pharmaceuticals, and food. Operates as the primary regulatory authority under the Thai Ministry of Public Health.
MOPH
Ministry of Public Health Thailand
Responsible for developing national health policies, regulatory frameworks, and technical standards, overseeing Thailand FDA operations and enforcement
TISI
Thai Industrial Standards Institute
Responsible for developing mandatory product standards and certification, ensuring specific product categories comply with Thai national standards
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to Thailand medical device regulations (Class 1,2,3)
Technical Documentation Preparation
Prepare complete Thai technical documentation including product specifications, test reports, quality system certificates
Local Representative Appointment
Appoint licensed authorized representative in Thailand responsible for registration and regulatory affairs
FDA Application Submission
Submit medical device license application and all technical documents to Thailand FDA
Technical Review
Pass Thailand FDA technical documentation review, sample testing and quality system assessment
Cosmetics Registration
Regulatory Requirements
- Cosmetic Product Notification
- Ingredient Safety Assessment Report (Thai language)
- Thai Product Labeling
- Good Manufacturing Practice Certification
- Product Information File
- Manufacturer Qualification Proof
- Ingredient Restrictions Compliance Proof
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Notification Submission
- Labeling Review Preparation
- Manufacturer Registration Completion
Registration Timeline
3-5 months
Official Fees
THB 15,000 - 150,000
Service Fees
$6,000 - $16,000
Regulatory System Overview
Thailand FDA
Thailand Food and Drug Administration
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, food supplements, pharmaceuticals, and food. Operates as the primary regulatory authority under the Thai Ministry of Public Health.
MOPH
Ministry of Public Health Thailand
Responsible for developing national health policies, regulatory frameworks, and technical standards, overseeing Thailand FDA operations and enforcement
TISI
Thai Industrial Standards Institute
Responsible for developing mandatory product standards and certification, ensuring specific product categories comply with Thai national standards
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Thailand cosmetic regulations permitted and restricted lists
Safety Assessment Report
Prepare Thai product safety assessment report signed by qualified assessor
Notification Submission
Submit cosmetic product notification application and related documents to Thailand FDA
Labeling Compliance Review
Ensure product labeling fully complies with Thailand cosmetic labeling regulations
Manufacturer Registration
Complete manufacturer registration procedures with Thailand FDA
Food Supplements Registration
Regulatory Requirements
- Food Supplement Notification
- Ingredient Safety and Quality Standards Proof
- Thai Product Labeling
- Good Manufacturing Practice Certification
- Health Claims Compliance Proof
- Nutritional Composition Analysis Report
- Manufacturer Registration Certificate
Main Process
- Product Classification Confirmation
- Technical Documentation Preparation
- Notification Submission
- Labeling Review Preparation
- Manufacturer Registration Completion
Registration Timeline
4-7 months
Official Fees
THB 25,000 - 200,000
Service Fees
$8,000 - $22,000
Regulatory System Overview
Thailand FDA
Thailand Food and Drug Administration
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, food supplements, pharmaceuticals, and food. Operates as the primary regulatory authority under the Thai Ministry of Public Health.
MOPH
Ministry of Public Health Thailand
Responsible for developing national health policies, regulatory frameworks, and technical standards, overseeing Thailand FDA operations and enforcement
TISI
Thai Industrial Standards Institute
Responsible for developing mandatory product standards and certification, ensuring specific product categories comply with Thai national standards
Food Supplements Registration Process
Product Classification Confirmation
Confirm product meets Thailand food supplement definition and does not fall under drug category
Technical Documentation Preparation
Prepare Thai technical documents including ingredient analysis, safety evidence, quality specifications
Notification Submission
Submit food supplement notification application to Thailand FDA
Labeling Review
Ensure labeling complies with Thailand food labeling regulations
Claims Compliance Review
Review all health claims for compliance with Thailand food claims regulations