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Thailand

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.

70M

Population

$515B

GDP (2023)

2,000+

TIS Standards

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

Strategic ASEAN hub location

Strong manufacturing sector and supply chains

ASEAN Directive alignment for devices and cosmetics

Modernizing digital compliance systems

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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Regulations & Requirements

Key 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.

• Compulsory TIS mark for appliances, toys, safety equipment

• Type testing and factory audits required

• Voluntary certification available for non-regulated products

Thai FDA

Food and Drug Administration regulates food, beverages, cosmetics, medical devices, and hazardous household substances with pre-market registration requirements.

• Food registration or notification required

• Cosmetics follow ASEAN notification system

• Medical devices: risk-based classification (Classes I-IV)

NBTC Type Approval

National Broadcasting & Telecommunications Commission mandates certification for all radio frequency and telecom network equipment.

• Covers mobile phones, Wi-Fi, Bluetooth, drones

• Testing to NBTC technical standards required

• QR code labeling system for traceability

Energy Label No.5

Voluntary but widely-adopted energy efficiency program with 94% consumer adoption for appliances. Rated 1-5 stars for energy performance.

• Covers air conditioners, refrigerators, TVs, fans

• De facto market requirement despite voluntary status

• Testing with EGAT for efficiency rating

Consumer Protection (OCPB)

Office of Consumer Protection Board enforces Thai-language labeling requirements and advertising standards across all consumer products.

• Mandatory Thai labels with product details

• Sector-specific labeling rules (electronics, textiles)

• Product safety and advertising oversight

Hazardous Substances

Multi-agency framework classifying chemicals into Types 1-4 based on risk, with registration and licensing requirements for household and industrial chemicals.

• Thai FDA regulates household chemicals

• Hazard labeling with Thai safety instructions

• Voluntary RoHS standard (TIS 2368)

Product Requirements

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.

Compliance Journey

Your Thailand compliance process

Follow these steps to ensure your products meet Thai requirements

1

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).

2

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.

3

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.

4

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).

5

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 Documents

Key laws and regulations for Thailand

Essential legal framework governing product compliance

Primary Legislation

Industrial Product Standards Act, B.E. 2511 (1968)

Establishes TISI and national standards system with mandatory certification procedures
Food Act, B.E. 2522 (1979)

Core food and beverage regulation with licensing and labeling requirements
Cosmetics Act, B.E. 2558 (2015)

ASEAN-aligned notification system for cosmetic products
Medical Device Act, B.E. 2562 (2019)

Risk-based classification system (Classes I-IV) aligned with ASEAN Medical Device Directive

Sectoral Regulations

Consumer Protection Act, B.E. 2522 (1979)

Labeling, advertising, and product liability framework enforced by OCPB
Hazardous Substances Act, B.E. 2535 (1992)

Chemical control with Types 1-4 classification and registration requirements
Telecommunications Business Act, B.E. 2544 (2001)

NBTC authority for telecom equipment type approval and technical standards
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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