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.