Legislation Overview
TH-Unique · Medical Device Act B.E. 2562 · B.E. year system
Primary Legislation
Medical Device Act B.E. 2562 (2019) — In Force 15 February 2021
This Act is the cornerstone of Thailand's medical device regulatory framework.
| Provision | Detail |
|---|---|
| Scope | All medical devices (instruments, apparatus, software, reagents) intended for human use |
| Classification | Class 1–4 risk-based (ASEAN AMDD aligned) |
| Three pathways | Listing (Class 1) · Notification (Class 2–3) · License (Class 4) |
| Establishment License | Mandatory for all manufacturers and importers |
| 5-year validity | All approvals expire after 5 years |
| AR requirement | Thai AR required for foreign manufacturers |
| Post-market | Vigilance, recall, PMS obligations |
| Enforcement | Thai FDA inspection, recall, licence suspension powers |
Medical Device Act B.E. 2551 (2008) — Predecessor
The 2008 Act governed device regulation before the 2019 Act came into force. Devices registered under the old framework are subject to renewal under the new 2019 Act framework.
B.E. Year Conversion Table
| B.E. | CE |
|---|---|
| 2551 | 2008 |
| 2562 | 2019 |
| 2564 | 2021 |
| 2566 | 2023 |
| 2568 | 2025 |
| 2569 | 2026 |
MoPH Notifications
Ministerial Notifications under the MoPH provide operational detail for the Act:
| Notification | Content |
|---|---|
| MoPH Notification on Risk Classification (B.E. 2562) | Defines Class 1–4 classification rules using ASEAN AMDD principles |
| MoPH Notification 137 — Labelling | Specifies labelling requirements including Thai language mandate for home-use devices |
| CSDT submission guidelines | CSDT Full format requirements for Class 2–4 applications |
| Grouping guidance | Six grouping types and eligibility criteria |
| Positive List for Class 1 devices | List of Class 1 devices eligible for the Listing pathway |
ASEAN Instruments
| Instrument | Role in Thailand |
|---|---|
| ASEAN Medical Device Directive (AMDD) | The harmonised framework that Thailand's Medical Device Act B.E. 2562 implements |
| ASEAN Common Submission Dossier Template (CSDT) | The dossier format mandated for Class 2–4 applications in Thailand |
| ASEAN CSDT guidance documents | Section-by-section guidance on CSDT preparation |
Related Legislation
| Law | Relevance |
|---|---|
| Communications Act / NBTC Act | Governing NBTC's authority over wireless device approvals |
| Consumer Protection Act | Post-market advertising and consumer safety obligations |
| Industrial Products Standards Act | Certain device-adjacent products may fall under industrial product standards |
How to Access Thai Legislation
- Thai FDA website: www.fda.moph.go.th — official MoPH Notifications, guidance documents, Positive List, CSDT templates
- Royal Thai Government Gazette — official publication of all acts and ministerial notifications
- ASEAN CSDT guidance — available from ASEAN Secretariat and member NRA websites including Thai FDA
B.E. vs CE dates
Always verify whether a document date is B.E. or CE. Thai regulatory documents use B.E. consistently — subtract 543 to convert to CE year.