The Thai Food and Drug Administration (FDA) has announced updates to the establishment registration form for the manufacturing, import, and sale of medical devices. This revision enhances regulatory oversight in line with the digital age, aiming to cover new technologies, particularly Standalone Medical Software, while reducing bureaucratic steps for entrepreneurs

In cases where identity verification cannot be completed via the Thai ID application as required by the system, the authorizer or the authorized person may instead use the document-based identity verification method. Power of Attorney (POA) to the Thai FDA is to formally authorize a representative, often a local agent

The Thai FDA has issued guidelines for the registration of patient-specific dental medical devices under Risk Classification 2–4. The key consideration is that product properties are assessed based on the primary raw materials rather than the finished product. Read the full infographic here: กองควบคุมเครื่องมือแพทย์  (Thai FDA Official Website in Thai).

In accordance with the new Thai FDA Change Notification guidelines, the Thai FDA has revised the amendment timeframes within the Change Notification System. The updated requirement applies to newly submitted Change Notification applications starting from 20 April 2026. Read the full press release here: กองควบคุมเครื่องมือแพทย์ (Thai FDA Official Website in