andamanmedical

On August 20, 2025, the Thai Food and Drug Administration (Thai FDA) issued Announcement (Issue No. 13) B.E. 2568 (2025), updating the list of experts, expert organizations, government agencies, and private organizations—both domestic and foreign—authorized to perform duties in evaluating academic documents for medical devices. This announcement is made under Section 35/2, Paragraph One of […]

On July 22, 2025, the Thai Food and Drug Administration (Thai FDA) introduced updated prescribed forms for the renewal of medical device notifications and licenses, replacing the previous versions outlined in the 2021 announcements. This update is issued under Section 12 of the relevant Ministerial Regulations and ensures that the forms align more closely with

In an effort to ease the renewal process for medical device licenses and notifications, the Thai FDA has introduced exemptions for certain documents and information, which took effect on the 22nd of July 2025.  This change applies to licensees or notifiers who face difficulties in renewing their licenses or notifications. The decision comes under Section

On July 23, 2025, the Thai Food and Drug Administration (Thai FDA) announced a new system for the renewal of medical device licenses and notification certificates, to be submitted annually through the SKYNET online platform. To view the official announcement and infographic, refer to:กองควบคุมเครื่องมือแพทย์ (Medical Device Control Division) Key Highlights Annual Renewal Period Medical device

On July 18, 2025, the Thai Food and Drug Administration (FDA) issued a press release clarifying the differences between the Document Addition System (Upgrade to Full CSDT) and the Renewal System within SkyNet, the regulatory platform for medical device registrations. This clarification is critical for stakeholders managing existing licenses or notification certificates. To view the

On July 18, 2025, the Ministry of Public Health, acting on the recommendation of the Medical Device Committee, issued an announcement revising the official list of designated inspection points for imported medical devices. This update repeals and replaces the previous Announcement dated December 14, 2023 (B.E. 2566). To view the official announcement (in Thai), refer