Thailand’s Food and Drug Administration finalized its Medical Device Labeling Regulation (B.E. 2568) on December 22, 2025. The regulation consolidates prior fragmented rules into a single framework. Mandatory compliance needs to start by June 20, 2026. The new rules clarify labeling content, language requirements, and post-import obligations.
The regulation specifies minimum label and IFU content across all device classes, with a focus on reusable devices. For such products, information regarding sterilization cycles, storage conditions, and post-opening shelf life (if applicable) must be clearly stated. Higher-risk devices, such as implants and some SaMD products, are expected to face closer scrutiny to ensure consistency with registration dossiers.
In terms of language requirements, home-use devices must include labeling and IFUs in Thai. Devices for professional use may have English labeling if it is appropriate for clinical users.
Digital tools such as QR codes and electronic IFUs are permitted, particularly for software and connected devices. Digital content must be synchronized with approved documentation and accessible offline. However, paper IFUs may still be required for certain high-risk products.
Last but not least, importers must complete compliant in-country labeling within 120 days of license issuance. Failure to meet this deadline may result in suspension of distribution. The regulation makes clear that proper labeling for medical devices is now essential to keeping products legally on the Thai market.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.