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 Controlling Thai FDA notification dated 9 May 2024, published in the Royal Gazette (Vol. 141, Special Part 153 Ng, pp. 1–3) on 5 June 2024 and effective the following day. The English title here is a descriptive rendering of the official Thai title: ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง กำหนดข้อมูล เอกสาร หรือหลักฐานที่ไม่ต้องแจ้งตามกฎกระทรวงว่าด้วยเรื่องการอนุญาตและการออกใบอนุญาตผลิตหรือนำเข้าเครื่องมือแพทย์ และการแจ้งรายการละเอียดและการออกใบรับแจ้งรายการละเอียดผลิตหรือนำเข้าเครื่องมือแพทย์ พ.ศ. 2567. The formerly linked English Thai FDA news item is descriptive secondary material, not the controlling instrument, and has been removed from the citeable corpus. The official Gazette PDF is retained as the exact source but remains blocked pending a reliable extraction/OCR path because its embedded text layer is damaged. | Registration | 2024-06-06 | 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 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 |
| 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 |
| 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 |
| 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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