How Thai FDA Medical Device Registration Works
Importing or manufacturing medical devices and aesthetic clinic equipment in Thailand requires Establishment Licensing (Importer License สน.1 or Manufacturer License ผพ.1) followed by Product Registration under ASEAN Medical Device Directive (AMDD) risk classes (Class 1 to Class 4) using CSDT technical files, ISO 13485, Certificate of Free Sale (CFS), and Letter of Authorization (LOA), plus obtaining a Medical Device Advertising License (ฆพ.).
4 Steps to Seamless Success: Fast, Compliant, Guaranteed
IntBizTH guides every milestone from initial assessment to formal regulatory license issuance
Free Document Audit & Assessment
Submit product specifications and dossiers for instant feasibility check and zero-delay timeline assessment.
Technical Dossier Preparation
Full compliance drafting, professional bilingual translation, formulation verification, and legal filing readiness.
Government Submission & Expedited Tracking
Direct liaison with regulatory agencies (FDA, TISI, Customs, CIQ) with active milestone tracking.
100% Certified License Handover
Delivery of certified official licenses and continuous guidance for commercial rollout.
Need expedited assistance with “Complete Guide to Thai FDA Medical Device Registration (Class 1–4, Importer License & ฆพ. Ad Permit)” without compliance delays?
Contact our bilingual specialists via LINE @intbizth or hotline. Over 20 years of experience ensuring 100% compliant approvals within 15 minutes response.
