Thai FDA Registration Services for Foreign Companies
Thai FDA Registration / Medical Devices / Cosmetics Notification / Food & Supplements / Storage & Warehouse Permits / License Renewal
Navigating Thailand's Food and Drug Administration (Thai FDA) regulatory framework can be challenging for foreign businesses. IntBizTH provides comprehensive regulatory compliance, formulation review, GMP warehouse layout design, and rapid e-Submission services. Our multilingual regulatory team ensures 100% first-time approval without costly delays or rejection risks.
Hotline (10 Channels) - IntBizTH Thailand Headquarters
Bangkok Head Office: Mon–Fri (09:00 – 18:00 ICT)
Introduction to Thai FDA Services
IntBizTH has over 20 years of specialized experience helping multinational corporations and global brands obtain Thai FDA certification swiftly and legally.
Official Thai FDA Government Fee & Timeline Matrix
Transparent statutory timelines and regulatory schedules. Full assistance with document preparation and e-Submission.
| License Category / Scope | Scope of Work & Compliance | Approval Guarantee | Estimated Timeline |
|---|---|---|---|
| Cosmetics Notification (10/13-Digit Code) | 100% INCI formula review, bilingual packaging compliance, e-Submission filing | 🏆 100% Approval Guarantee | 7–14 Working Days |
| Food & Beverage Approval (13-Digit Serial) | GMP/GHP premises audit, nutritional lab testing, SorBor.5/7 & Form Or.18 filing | 🏆 100% Approval Guarantee | 15–30 Working Days |
| Medical Device Class 1 (Listing) | Establishment licensing, device listing review, compliant English/Thai IFU artwork | 🏆 100% Approval Guarantee | 15–30 Working Days |
| Medical Device Class 2–4 (Notification/Registration) | CSDT dossier drafting, DMF verification, risk assessment & clinical evaluation | 🏆 100% Approval Guarantee | 30–60 Working Days |
| GMP Warehouse & Storage Facility Permits | Architectural blueprint layout, temperature SOPs, physical Thai FDA site audit | 🏆 100% Approval Guarantee | 15–45 Working Days |
| Advertising Permits (ฆอ. / ฆพ. / ฆท.) | Digital marketing ad script review, social media legal clearance & official permit | 🏆 100% Approval Guarantee | 7–14 Working Days |
🔍 คลิกเพื่อดูแผนผังขนาดเต็ม (Click to expand)
Product Categories Requiring Thai FDA Approval
IntBizTH covers all 5 health product sectors regulated by the Ministry of Public Health:
1. Medical Devices FDA Registration (Class 1–4)
- Import, export, and manufacturing licenses for all Medical Devices (Class 1 to 4)
- Device establishment licensing, CSDT technical dossier drafting & regulatory clearance
- Import authorization for raw materials, medical parts, diagnostics (IVD), and spare parts
2. Cosmetics & Skincare FDA Notification
- Cosmetic import license & GMP manufacturing/storage premises certification
- 100% INCI formula compliance screening and issuance of official 10/13-digit Thai FDA codes
- Legally compliant Thai bilingual packaging artwork layout & Product Information File (PIF)
3. Food, Beverages & Dietary Supplements FDA
- Import License (Form Or.7/8) and GMP/GHP facility inspection certification
- 13-digit Food Serial Number approval (SorBor.5 / SorBor.7 / Form Or.18 food registration)
- Nutritional analysis verification and Khor-Or (ฆอ.) advertising license approval
4. Household Hazardous & Disinfectant Products
- Import and manufacturing permits for household chemical/cleaning agents (Form WorOr.)
- SDS/MSDS toxicity profile review and laboratory heavy metal test certification
- Compliance with Thailand Hazardous Substance Act B.E. 2535 standards
5. Pharmaceuticals, Modern Drugs & Herbal Products
- Importation & distribution licenses for modern drugs, APIs, and herbal products
- GSP-compliant temperature-controlled warehouse auditing and Qualified Pharmacist liaison
- Khor-Thor (ฆท.) pharmaceutical advertising clearance and full ACTD dossier preparation
Why Global Enterprises Choose IntBizTH for Thai FDA
20+ years of dedicated Thai regulatory experience, zero document rejection, and end-to-end legal coverage.
Fast-Track Processing
Direct e-Submission pipeline with continuous officer follow-up, minimizing idle wait.
Transparent Fixed Pricing
Clear breakdown of official government fees and consulting costs with zero hidden charges.
Full Turnkey Service
No need to navigate Thai bureaucracy in person; we handle blueprints, tests, and translation.
10M THB Capital Entity
Fully accredited Thai corporation established since 2005 with corporate invoicing & contracts.
100% Legal Guarantee
Strict adherence to Thai FDA acts, Ministerial regulations, and ASEAN harmonized standards.
Full Lifecycle Management
From premises setup to FDA number issuance and post-market digital advertising permits.
Thai FDA & Advertising Licenses (Khor-Or / Khor-Phor / Khor-Thor)
Marketing health products in Thailand requires mandatory advertisement permits. We manage both product registration and advertising legal clearance.
Khor-Thor: Pharmaceutical Ads
Official regulatory permit required before public advertising of pharmaceuticals.
Read Full Legal Guide →
Khor-Phor: Medical Device Ads
Mandatory advertising clearance for all Class 1-4 medical devices & diagnostic kits.
Read Full Legal Guide →
Khor-Or: Food & Supplement Ads
Crucial permit for social media and e-commerce campaigns for food & supplements.
Read Full Legal Guide →
Comprehensive Advertising Matrix
Executive summary of statutory validities, renewal rules, and timeline guides.
Read Full Legal Guide →
Free Regulatory Assessment
Connect with our 20+ years bilingual regulatory specialists via LINE @intbizth.
Read Full Legal Guide →Frequently Asked Questions (FAQ) on Thai FDA
Can a foreign company apply for Thai FDA directly without a local entity?
Under Thai law, the Thai FDA does not grant licenses directly to overseas entities. An applicant must either: 1. Establish a registered Thai corporate entity (with appropriate commercial business objectives); or 2. Appoint a licensed Thai regulatory agent/importer (such as IntBizTH) to hold the product registration. IntBizTH can provide end-to-end setup including corporate registration, GMP warehouse licensing, and FDA approvals.
What is the typical timeline for obtaining Thai FDA approval?
Timelines vary by product classification and risk level: Cosmetic notifications typically take 7–14 working days; Food & Dietary Supplements require 15–30 working days; Medical Devices range from 15–30 days for Class 1 (Listing) up to 60–120 days for Class 2–4 (Notification & Registration) involving full CSDT dossier review.
Is a GMP-certified warehouse or premises inspection mandatory in Thailand?
Yes. Thai FDA regulations strictly require that imported health products be stored in a facility that satisfies national Good Storage Practice (GSP/GMP) standards. Thai FDA officials conduct physical or virtual site audits. IntBizTH assists with warehouse architectural blueprint layout, temperature/humidity standard operating procedures (SOP), and audit facilitation.
What key documents are required for cosmetic notifications in Thailand?
Essential documentation includes: 1. Complete quantitative formulation breakdown (100% INCI); 2. Certificate of Free Sale (CFS) or GMP/ISO 22716 certificate from country of origin; 3. Legalized Letter of Authorization (LoA); 4. Thai bilingual packaging & labelling artwork; 5. Product Information File (PIF) and safety test reports.
What are the regulatory requirements for medical devices (Class 1–4)?
Under the Medical Device Act B.E. 2562, imported medical devices require an establishment license followed by CSDT technical dossiers: Device Master File (DMF), Risk Management Plan (ISO 14971), Essential Principles Checklist, Certificate of Analysis, and Thai Instructions for Use (IFU).
Do we need separate advertising permits to run ads or sell online in Thailand?
Yes! Marketing and advertising health products in Thailand is strictly governed by law. Food & supplements require 'Khor-Or' (ฆอ.) permits, medical devices require 'Khor-Phor' (ฆพ.) permits, and drugs require 'Khor-Thor' (ฆท.) permits. Advertising without prior approval incurs heavy fines and suspension. IntBizTH manages product registration and advertising legal clearance simultaneously.