Confirm the local establishment
Thai FDA’s commercial manufacture and import guidance states that businesses wishing to manufacture or import medical devices commercially must register their establishment. Assess the proposed local importer and its authorisations before planning a commercial shipment.
Determine the product pathway
Thai FDA describes four risk classes and publishes different documentation requirements. Its guidance distinguishes listed Class 1 devices, notified Class 2–3 devices and licensed Class 4 devices. Confirm classification using the actual intended use and device characteristics, rather than assuming that an overseas class maps automatically to Thailand.
Coordinate evidence and ongoing obligations
The official guidance lists dossier elements such as labels, instructions for use and authorisation documents, and points to post-market obligations. We recommend maintaining a country-specific evidence checklist, verifying local language requirements and allocating responsibility for post-market communication before launch.
Official sources
Thai FDA — Manufacture / Import for Commercial Purposes ↗Sources accessed on 14 November 2026. Planning recommendations are identified in the text. Requirements may change; confirm the current position with the relevant authority.