Skip to main content

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).

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
  • Establishment Licensing — mandatory Establishment License, Thai AR, e-submission, NBTC
  • Post-Market — vigilance, FSCAs, labelling, Thai language requirements, renewal
  • Legislation — Medical Device Act B.E. 2562, MoPH Notifications, ASEAN instruments
  • Guidance & Resources — CSDT templates, timelines, fee schedule

Part of the RAPath suite.