Thailand
Navigate Thailand's comprehensive regulatory framework with TISI certification, Thai FDA registration, NBTC approvals, and voluntary quality programs for Southeast Asia's dynamic consumer market.
Key Requirements Overview
TISI Certification
Mandatory TIS standards for regulated products
Thai FDA
Food, cosmetics, medical devices, chemicals
NBTC Type Approval
Mandatory for all wireless/telecom equipment
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Thailand Dynamic ASEAN market with robust quality standards
Thailand's 70 million consumers represent a sophisticated Southeast Asian market with comprehensive product safety and quality regulations. The Thai Industrial Standards Institute (TISI) oversees over 2,000 standards, while the Thai FDA regulates health-related products, and NBTC controls telecom equipment. Thailand combines mandatory compliance requirements with innovative voluntary programs like the widely-adopted Energy Label No.5.
Market Advantages
Regulatory Framework
Thailand's multi-agency approach ensures comprehensive oversight. TISI manages product standards and certification, the Thai FDA regulates health and consumer safety products, NBTC controls telecom equipment, and OCPB enforces consumer protection labeling.
Thailand also promotes voluntary quality programs like Energy Label No.5 (94% consumer adoption) and Made in Thailand certification.
Quick Facts
- Official Language
- Thai (English for business)
- Currency
- Thai Baht (THB)
- Standards Body
- TISI (Thai Industrial Standards Institute)
- Key Regulators
- Thai FDA, NBTC, OCPB, Ministry of Industry
- ASEAN Member
- Yes (regional harmonization)
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Contact Thailand ExpertKey Thailand regulations
Understanding Thailand's mandatory and voluntary compliance landscape
TISI Certification
Thai Industrial Standards Institute manages 2,000+ standards with mandatory certification for regulated products and voluntary programs for quality assurance.
Thai FDA
Food and Drug Administration regulates food, beverages, cosmetics, medical devices, and hazardous household substances with pre-market registration requirements.
NBTC Type Approval
National Broadcasting & Telecommunications Commission mandates certification for all radio frequency and telecom network equipment.
Energy Label No.5
Voluntary but widely-adopted energy efficiency program with 94% consumer adoption for appliances. Rated 1-5 stars for energy performance.
Consumer Protection (OCPB)
Office of Consumer Protection Board enforces Thai-language labeling requirements and advertising standards across all consumer products.
Hazardous Substances
Multi-agency framework classifying chemicals into Types 1-4 based on risk, with registration and licensing requirements for household and industrial chemicals.
Requirements by product category
Understanding which regulations apply to your products
Electronics & Electrical
TISI Mandatory + Energy Label No.5
Compulsory TIS safety standards for appliances (IEC-aligned), voluntary Energy Label No.5 (de facto required), Thai labeling, 220V/50Hz compliance. Voluntary RoHS (TIS 2368).
Telecom & Wireless
NBTC Type Approval (Mandatory)
All RF/telecom equipment requires NBTC certification. Testing to NBTC standards, local representative needed, QR code labeling system. Special permits for drones and satellite equipment.
Food & Beverages
Thai FDA Registration/Notification
Pre-market approval for controlled foods, notification for others. Thai labels mandatory with FDA number, nutrition facts, allergen warnings. GMP compliance for factories. Alcoholic beverages need health warnings.
Cosmetics
ASEAN Cosmetic Directive (Notification)
Online notification system with Thai FDA. ASEAN ingredient compliance (prohibited/restricted lists). Thai labels with INCI ingredients, notification number. ASEAN GMP guidelines. Authorization from brand owners required.
Medical Devices
Thai FDA Registration (Classes I-IV)
Risk-based ASEAN-harmonized system. Class I: notification, Classes II-III: registration, Class IV: full licensing. ISO 13485 required, local MAH needed. Thai instructions mandatory. Expedited review for FDA/CE/HSA approved devices.
Toys & Children's Products
TIS 685 Mandatory Certification
Compulsory TIS 685-2562 (ISO 8124 aligned) since Sept 2022. Mechanical/physical safety, flammability, heavy metal limits. Type testing and factory audit required. Thai age warnings and usage instructions mandatory.
Textiles & Apparel
OCPB Labeling Requirements
Thai labels with fiber content, care instructions, size, manufacturer/distributor. Voluntary Thai Green Label for low-hazard textiles. "Made in Thailand" certification (40% local content) for government procurement preference.
Chemicals & Household
Hazardous Substances Act
Type 1-4 classification based on risk. Thai FDA registration for household chemicals (Type 2-3). Hazard labeling in Thai with symbols, first aid, disposal instructions. Thai SDS required. Voluntary RoHS for electronics.
Food Contact Materials
Thai FDA Standards
MOPH quality standards for ceramic, metal, plastic food containers prevent heavy metal/chemical leaching. Melamine kitchenware: formaldehyde migration limits. All food packaging must meet safety specifications.
Voluntary Quality Programs
Market Differentiators
Thailand Green Label (eco-products), Made in Thailand (40% local content), Thailand Quality Mark (premium products), Halal certification, Organic Thailand label. All voluntary but provide market advantages.
Household Goods
General Consumer Protection
Product safety under Consumer Protection Act, Thai labeling via OCPB. Food-contact items need MOPH compliance. Batteries classified as hazardous waste with recycling requirements. Product liability standards apply.
Batteries & E-Waste
Environmental Compliance
Lithium batteries need UN-compliant design, Thai safety instructions. Lead-acid batteries require DIW/FDA permits. Import ban on e-waste (463 items). Voluntary recycling programs for batteries and electronics.
These are the basic requirements. Individual product types may have additional obligations.
Please contact SANTIQ for complete requirements specific to your products.
Your Thailand compliance process
Follow these steps to ensure your products meet Thai requirements
Identify Applicable Regulations
Determine product category and regulatory scope. Check TISI mandatory product lists, Thai FDA controlled products, NBTC equipment categories, and Hazardous Substance List. Some products require multiple certifications (e.g., smart devices need both TISI and NBTC).
Product Testing & Documentation
Conduct testing to Thai or international standards at TISI-accredited labs. Prepare technical documents including user manuals in Thai, ingredient lists, Safety Data Sheets, and test reports. Translate key documents into Thai for regulatory submissions.
Appoint Local Representative
Engage a Thai entity (subsidiary, distributor, or agent) to handle regulatory submissions. Ensure they obtain required licenses (Thai FDA import license, factory licenses if manufacturing locally). Consider pre-consultation meetings for complex products.
Regulatory Submissions
Submit applications: TISI certification (type testing + factory audit), NBTC type approval (technical dossier), Thai FDA registration/notification (e-submission portals), hazardous substance registration if needed. Processing times vary from immediate (cosmetic notifications) to several months (Class IV medical devices).
Product Labeling & Marking
Apply required marks: TIS mark and license number for certified products, NBTC QR code for telecom devices, FDA registration numbers on food/cosmetics. Ensure comprehensive Thai-language labels with all mandatory information, warnings, and instructions.
Customs Clearance & Market Entry
Import through National Single Window with all permits and certificates. Customs system verifies FDA licenses electronically. Affix Thai labels before market release. Maintain licenses (TISI certificates typically valid 3 years), monitor regulatory updates, and implement post-market surveillance for adverse events.
Key laws and regulations for Thailand
Essential legal framework governing product compliance
Primary Legislation
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Industrial Product Standards Act, B.E. 2511 (1968)Establishes TISI and national standards system with mandatory certification procedures
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Food Act, B.E. 2522 (1979)Core food and beverage regulation with licensing and labeling requirements
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Cosmetics Act, B.E. 2558 (2015)ASEAN-aligned notification system for cosmetic products
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Medical Device Act, B.E. 2562 (2019)Risk-based classification system (Classes I-IV) aligned with ASEAN Medical Device Directive
Sectoral Regulations
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Consumer Protection Act, B.E. 2522 (1979)Labeling, advertising, and product liability framework enforced by OCPB
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Hazardous Substances Act, B.E. 2535 (1992)Chemical control with Types 1-4 classification and registration requirements
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Telecommunications Business Act, B.E. 2544 (2001)NBTC authority for telecom equipment type approval and technical standards
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Thai Industrial Standards (TIS)2,000+ standards including TIS 685 (toys), TIS 60335 (appliances), TIS 2368 (RoHS)
ASEAN Harmonization
Thailand implements ASEAN Cosmetic Directive and ASEAN Medical Device Directive, enabling regional harmonization. Many TIS standards align with ISO/IEC international standards. Monitor the Royal Gazette (Ratchakitcha) for new regulatory announcements.
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