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Thailand Medical Device Regulation

Regulatory authority: Thai FDA / Medical Device Control Division (MDCD) | Legislation: Medical Device Act B.E. 2562 (2019), in force 15 February 2021 | Last reviewed: May 2026 | For reference only — not legal advice.

Thailand regulates medical devices through the Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA), under the Ministry of Public Health. The current legal framework — the Medical Device Act B.E. 2562 (2019) — came into full effect on 15 February 2021, replacing the former framework and bringing Thailand into alignment with the ASEAN Medical Device Directive (AMDD).

Regulatory Pathway Map​

Click a phase to expand — each card links to the relevant section of this guide.

Getting Started
What is a Medical Device?
Definition under the Thai Medical Device Act B.E. 2562 (2019) — scope and exclusions.
Read definition →
Getting Started
Regulatory Framework
Thai FDA / MDCD structure, the Medical Device Act, and overview of licensing obligations.
View framework →
Getting StartedKey step
Who Must Comply?
Import licence and establishment licensing obligations for manufacturers, importers, and distributors.
Check obligations →

Key Facts​

Regulatory bodyThai FDA / Medical Device Control Division (MDCD)
Primary lawMedical Device Act B.E. 2562 (2019) — in force 15 Feb 2021
ClassificationClass 1 (low) · 2 · 3 · 4 (high) — ASEAN AMDD
Three pathwaysListing (Class 1) · Notification (Class 2–3) · License (Class 4)
Approval validity5 years — all approval types
Establishment LicenseMandatory for all manufacturers and importers
AR requiredYes — Thai Authorized Representative for foreign manufacturers
CSDT dossierCommon Submission Dossier Template (Full for Class 2–4)
NBTC reviewSeparate NBTC approval required for wireless/Bluetooth/Wi-Fi devices
B.E. year systemThai calendar adds 543 to CE year (2021 CE = B.E. 2564)

What This Site Covers​

  • Getting Started — definitions, Thai FDA/MDCD structure, B.E. year guide, ASEAN alignment, who must comply
  • Classification — ASEAN AMDD Class 1–4, IVD rules, Positive List, SaMD, combination products
  • Three Approval Pathways — Listing / Notification / License, 5-year validity, expedited/reliance route
  • CSDT & Documentation — Full CSDT format, grouping rules, QMS, essential principles, clinical evidence
  • Establishment Licensing — mandatory Establishment License, Thai AR, e-submission, NBTC
  • Quality System — ISO 13485, Thai GMP, MDCD inspections
  • Digital Health — SaMD framework, AI/ML, cybersecurity, IEC 62304
  • Post-Market — vigilance & AE reporting, recalls, PMS plan, labelling, Thai language, renewal
  • UDI — UDI requirements for Class 2–4 (draft guidance March 2025, 2-year transition)
  • Special Access — emergency authorisation, compassiona