Thai 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 dateSource-linked rules for common changes to a registered medical device. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
Yes
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Cancellation clause seen verbatim: เมื่อตำรับที่ขอถ่ายโอนเอกสารได้รับการอนุมัติ ทะเบียนตำรับแม่แบบจะถูกยกเลิก.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
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.
Keep Thailand as the target market while you move into registration records, classification, cross-country product research, or pathway planning.
Check a preliminary Thai FDA risk class.
Inspect public Thai FDA records.
Search the same product in multiple country registries.
Estimate pathway, government fees, preparation, and review time.
Structure company, product, model, approval, and evidence facts once.
Compare existing evidence against Thailand needs.
Connect route, evidence, labels, representatives, and launch dependencies.
Test a current Thai FDA update against one product and its evidence.
