Thailand is raising the bar for medical device software. A revised labeling regulation taking effect June 20, 2026, brings stricter documentation standards and, notably, the country’s first-ever unique device identification (UDI) requirement for software as a medical device (SaMD). The rule covers moderate and high-risk SaMD and puts Thailand in line with the ASEAN Medical Device Directive and the EU MDR.
One of the more practical updates is a formal green light for electronic instructions for use (IFU) via QR codes, websites, or other digital channels. If the software is consumer-facing, labels and IFU must be in the Thai language. Software aimed at healthcare professionals gets more flexibility, as Thai or English is acceptable.
All labels must include the product name and intended purpose, manufacturer or importer details, Thai FDA approval number, and lot or version number. Products already registered have a grace period, with existing labels remaining valid for up to two years from the effective date of this new regulation.
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.