The Thai Food and Drug Administration (Thai FDA) has published an infographic outlining the Change Notification System for Class 2–4 medical devices. The update explains how changes are categorized, the applicable processing timelines, correction periods, and government and expert assessment fees. Processing requirements differ depending on whether the proposed change

The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA) has introduced a Positive List pathway for eligible Class 1 low-risk medical devices, equivalent to ASEAN Class A. Qualifying products may use an auto-approval registration process, providing a more streamlined route to market. Under this

The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA) has issued guidance clarifying the circumstances in which certain medical device advertisements may be exempt from prior advertising approval. The exemption applies only where specified event, organizer, attendance, and notification conditions are met. Advertising materials

The Medical Device Control Division of the Thai Food and Drug Administration (Thai FDA) has issued guidance under its “Medical Device or Not?” series to clarify when contamination testing kits are considered medical devices in Thailand. The guidance emphasizes that classification depends primarily on the product’s intended purpose. No new

The Medical Device Control Division (MDCD) of the Thai Food and Drug Administration (Thai FDA) has issued guidance clarifying the labeling and Instructions for Use (IFU) requirements for Software as a Medical Device (SaMD) marketed in Thailand. The guidance outlines the minimum information expected on SaMD labels or IFUs and