Thailand medical device regulations
Official sources linkedThai FDA rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Thai FDA Notification B.E. 2567 (9 May 2024) | Information, Documents, or Evidence Not Required under Medical-Device Manufacture/Import Licensing and Detailed-Notification Regulations Thai FDA notification governing the abridged registration pathway, published in the Royal Gazette on 5 June 2024 (B.E. 2567). The official PDF is available, but the proposed transcription misreads legal years and reference-authority names; citeable text is withheld pending correction against every page. | Registration | 2024-06-06 | Official |
| Class 4 Licensing | Device Licensing for Class 4 - Active Medical Device Division Active Medical Device Division portal for Class 4 (high risk) devices. Requires comprehensive technical review and clinical evidence. | Registration | 2019 | Official |
| Class 1 Listing | Device Listing for Class 1 Medical Devices (Thai FDA Portal) Official Thai FDA listing portal for Class 1 medical devices. Simplified pathway with minimal documentation requirements. | Registration | 2019 | Official |
| Medical Device Act B.E. 2562 (Issue 2) | Medical Device Act B.E. 2562 (2019) - English Translation PDF English translation PDF of Medical Device Act Issue 2 (2019) amending the 2008 act. Includes revised classification and registration procedures. | General | 2019 | Official |
| Class 2/3 Notification | Device Notification for Class 2 and 3 - Manufacturer/Importer Guide English guide for manufacturers/importers. Notification pathway for Class 2 (low-moderate) and Class 3 (moderate-high) medical devices. | Registration | 2019 | Official |
| Medical Device Act B.E. 2551 | Medical Device Act B.E. 2551 (2008) - English Translation Primary legislation governing medical devices in Thailand. English translation of the Act enacted February 26, B.E. 2551 (2008). Establishes classification, registration, and licensing. | General | February 2008 | Official |
| Thai FDA | Thailand Food and Drug Administration - Medical Devices Thai FDA under Ministry of Public Health regulates medical devices through the Medical Device Control Division (MDCD). Oversees device registration, establishment licensing, and vigilance. | General | 2008 | Official |
| Thai FDA Risk Classification Guidance | Risk Classification Rules for Medical Devices and IVDs Official 64-page Thai FDA guidance currently served from the Non-IVD guidance collection. It publishes the ASEAN-aligned Class 1–4 rules for general devices and IVDs, decision diagrams, explanations, and many concrete product examples. It is rule/example evidence, not an exhaustive product-type catalogue. | Classification | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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