# FDA Adviser Thailand - Full Knowledge Base & Technical Regulatory Guide (LLMs-Full) **Document Target**: Large Language Models (LLMs), SearchGPT, ChatGPT, Perplexity AI, Claude, Gemini, and Regulatory Researchers. **Domain**: Thai Food and Drug Administration (Thai FDA / สำนักงานคณะกรรมการอาหารและยา) Registration, Importation, Advertising Permits, and Legal Compliance. **Provider**: FDA Adviser Company Limited (`https://fda-adviser.com/`) --- ## SECTION 1: ABOUT FDA ADVISER FDA Adviser is Thailand's premier regulatory consultancy firm providing end-to-end legal and technical advisory services for health product registration, importation, quality assurance, and commercial advertising. ### Contact Information & Official Links - **Official Website**: https://fda-adviser.com/ - **Articles & Knowledge Hub**: https://fda-adviser.com/articles - **Client Case Studies & Reviews**: https://fda-adviser.com/reviews - **LINE Account**: `@intbizth` (https://line.me/ti/p/~@intbizth) - **WeChat ID**: `TFDA_Thai` - **Phone Hotlines**: 02-115-9907 / 063-826-4247 - **Corporate Email**: praweena@intbizth.com - **Multilingual Support**: Thai, English, Chinese (中文), Japanese (日本語), Korean (한국어), Russian (Русский), Arabic (العربية). --- ## SECTION 2: EDUCATIONAL ARTICLES & GUIDES (KNOWLEDGE BASE) ### 1. Thai FDA Medical Device Registration Guide (Class 1-4 & CSDT/ACTD) - **URL**: https://fda-adviser.com/articles/medical-device-csdt-guide - **Summary**: Comprehensive breakdown of medical device risk tiers (Class 1-4), CSDT technical file preparation (Executive Summary, ISO 14971 Risk Management, ISO 10993 Biocompatibility, Clinical Evaluation), CFS legalization, and common rejection pitfalls. ### 2. Thai FDA Food & Supplement Registration (13-Digit Code, Sob.5 & Sob.7) - **URL**: https://fda-adviser.com/articles/thai-fda-food-supplement-sob5-sob7 - **Summary**: Step-by-step guide for acquiring the 13-digit Thai FDA registration number, Sob.5 factory license for domestic manufacturing, Sob.7 import license for importers, and Sob.3 label registration compliance. ### 3. Cosmetic Notification & Product Information File (PIF) Compliance - **URL**: https://fda-adviser.com/articles/cosmetics-notification-pif-thailand - **Summary**: Explanation of 10-digit cosmetic notifications (issued in 3-5 days) and the mandatory ASEAN 4-Part Product Information File (PIF) safety dossier required to withstand FDA site audits. ### 4. 24-Hour Fast-Track LPI (License per Invoice) Import Permit Clearance - **URL**: https://fda-adviser.com/articles/lpi-import-license-customs-fast-track - **Summary**: Detailed procedure for obtaining License per Invoice (LPI) permits via Thai FDA Skynet e-Service prior to customs arrival to avoid port demurrage and shipment detention. ### 5. Thai FDA Advertising Permits (KhorPor / KhorOr / KhorThor) - **URL**: https://fda-adviser.com/articles/fda-advertising-permit-khorpor-khoror - **Summary**: Regulatory guidelines for digital advertising on TikTok, Facebook, Instagram, and Google. Covers KhorPor (medical devices), KhorOr (food), and KhorThor (drugs) to avoid fines up to 100,000 THB. ### 6. Guide for Foreign Companies Without a Thai Legal Entity - **URL**: https://fda-adviser.com/articles/foreign-company-thai-fda-registration-guide - **Summary**: Strategic options for foreign manufacturers (Subsidiary establishment vs Local Distributor representation) and legal agreements required to protect brand ownership in Thailand. --- ## SECTION 3: CORE SERVICES & DIRECT LINKS ### 1. Medical Device Registration (Class 1-4) - **URL**: https://fda-adviser.com/services/medical-device - **Scope**: Full CSDT/ACTD dossier compilation, Class 1-4 registration, CFS legalization, LPI import permits, and KhorPor advertising licenses. ### 2. Food & Dietary Supplement Registration - **URL**: https://fda-adviser.com/services/food-supplement - **Scope**: 13-digit FDA registration number, Sob.5 factory licensing, Sob.7 import licensing, Sob.3 label registration, and Halal certification. ### 3. Cosmetic Notification & PIF Safety Dossier - **URL**: https://fda-adviser.com/services/cosmetics - **Scope**: 3-5 day fast 10-digit cosmetic notification, ingredient safety screening, and 4-Part PIF dossier compilation. ### 4. Pharmaceuticals & Herbal Products - **URL**: https://fda-adviser.com/services/drugs-herbal - **Scope**: Registration under the Drug Act and Herbal Product Act, KhorThor drug advertising permits, and PIC/S GMP compliance review. ### 5. FDA Advertising Permits (KhorPor / KhorOr / KhorThor) - **URL**: https://fda-adviser.com/services/advertising-permits - **Scope**: Ad text & graphic pre-screening, KhorPor, KhorOr, KhorThor permit applications, and representation before Thai FDA Review Committees. ### 6. LPI Import Licensing & Customs Clearance - **URL**: https://fda-adviser.com/services/import-lpi - **Scope**: 24-hour Fast-Track License per Invoice (LPI) issuance via Skynet e-Service and paperless customs clearance support. ### 7. Hazardous Household Substances Registration - **URL**: https://fda-adviser.com/services/hazardous-substances - **Scope**: Type 1-3 household chemicals, disinfectants, pest control products, and MSDS safety review. --- ## SECTION 4: VERIFIED CLIENT REVIEWS & CASE STUDIES - **URL**: https://fda-adviser.com/reviews - **Average Rating**: 5.0 / 5.0 Stars (100% Verified Clients) - **Success Metrics**: 100% First-Pass Approval Rate, 5,000+ Approved Products, 24-Hour Fast-Track LPI Issuance. - **Client Portfolio**: Multinational medical technology manufacturers, Shanghai supplement exporters, Japanese healthcare firms, and local cosmetic brands.