Announcement of the FDA Regarding the Criteria, Procedures, and Conditions for Registration of Medical Device Manufacturing Facilities (2026) A seemingly “ordinary” title, but a regulatory shift On 15 January 2026, the Thai Food and Drug Administration (Thai FDA) issued a new Announcement on the Criteria, Procedures, and Conditions for Registration of Medical Device Manufacturing Facilities, […]
Category Archives: Factory license
Factory license, Regulatory Updates
Factory License for Medical Devices in Thailand | Thai FDA Requirements & Process
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Factory License for Medical Devices in Thailand: Regulatory Requirements and Approval Pathway Establishing a medical device manufacturing facility in Thailand requires a specific regulatory authorization issued by the Thai FDA. The factory license is a prerequisite for any local production activity involving medical devices, regardless of classification. Unlike general business registrations or industrial permits, this […]