🇹🇭Thailand Medical Device Regulations

Abridged Pathway for Pre-Approved Devices - Reduced Documentation

Official announcement of abridged pathway (effective June 2024). Devices with 1+ year approval from US FDA, EU NB, TGA, MHLW, or HC qualify for streamlined evaluation.

Medical Device Act B.E. 2562 (2019) - English Translation PDF

English translation PDF of Medical Device Act Issue 2 (2019) amending the 2008 act. Includes revised classification and registration procedures.

Medical Device Laws and Regulations - Classification Guidelines

Thai FDA laws and regulations page. Thailand follows ASEAN risk-based classification: Class 1 (low risk), Class 2 (low-moderate), Class 3 (moderate-high), Class 4 (high risk).

Device Listing for Class 1 Medical Devices (Thai FDA Portal)

Official Thai FDA listing portal for Class 1 medical devices. Simplified pathway with minimal documentation requirements.

Device Notification for Class 2 and 3 - Manufacturer/Importer Guide

English guide for manufacturers/importers. Notification pathway for Class 2 (low-moderate) and Class 3 (moderate-high) medical devices.

Device Licensing for Class 4 - Active Medical Device Division

Active Medical Device Division portal for Class 4 (high risk) devices. Requires comprehensive technical review and clinical evidence.

Medical Device Act B.E. 2551 (2008) - English Translation

Primary legislation governing medical devices in Thailand. English translation of the Act enacted February 26, B.E. 2551 (2008). Establishes classification, registration, and licensing.

Thailand Food and Drug Administration - Medical Devices

Thai FDA under Ministry of Public Health regulates medical devices through the Medical Device Control Division (MDCD). Oversees device registration, establishment licensing, and vigilance.