Thailand Issues New Guidelines for Software as a Medical Device Registration

In May, the Thai Food and Drug Administration (TFDA) released new registration guidelines on Software as a Medical Device (SaMD) in Thailand. These guidelines are designed to establish regulations for software-based medical innovations and clarify pathways to reduce uncertainty and expedite market entry.

The TFDA‘s guidelines help determine if software qualifies as a medical device, which must be intended for preventing, diagnosing, treating, alleviating, or monitoring diseases in humans or animals. The guidelines categorize medical device software into four types: embedded software (integrated into a medical device), standalone software (can work independently), software accessories (used to improve the functionality of a medical device), and non-medical device software (not intended for medical use).

SaMD can be categorized into 3 classes. Essential documentation for class 1 SaMD products includes product specifications, labeling information, a certificate of conformity, and documentation of any foreign registration. A power of attorney may also be required if applicable. SaMD classified as Class 2 or Class 3 requires a more extensive documentation set. This includes detailed product descriptions, risk analysis, manufacturing and disposal procedures, quality system certificates, and registration history abroad. A power of attorney is necessary for importation.

Devices linked to external systems must maintain cybersecurity standards as well as safeguard personal data.

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.