Medical Device Act B.E. 2562 (2019) — Thailand's Modern Device Regulatory Framework
The Medical Device Act B.E. 2562 (2019), administered by the Thai Food and Drug Administration (Thai FDA), modernised Thailand's medical device regulatory framework. Key features include:
- Three-tier risk classification: Class 1 (lowest risk, notification), Class 2 (moderate risk, listing), Class 3 (highest risk, licence/registration) — aligned with ASEAN AMDD principles.
- Market authorisation pathways tailored to risk class, with Class 3 devices requiring a full Medical Device Licence (MDL) with technical dossier review.
- Mandatory adverse event reporting for manufacturers and importers.
- Post-market surveillance obligations proportionate to device class.
- Establishment licensing for all entities manufacturing, importing, distributing, or repackaging medical devices.
📅 Effective / published: 2019 (phased implementation)
Foreign manufacturers must appoint a Thai-based importer or authorised representative who holds the relevant Establishment Licence and takes regulatory responsibility for the device on the Thai market. Classification should be confirmed with the Thai FDA before submission, as Class 3 equivalence to AMDD classes B–D requires careful mapping.
View official source (Thai FDA — Medical Devices) ↗