Thailand's Food and Drug Administration (TFDA) has issued guidelines on May 9, 2024 for registration of software (SaMD) to determine whether SaMD software is suitable as a medical device. The guidelines for Software as a Medical Device (SaMD) registration are briefly as follows.  Type of medical device software >-       Embedded Software: Software embedded in medical devices-       Standalone So..

On May 27, 2024, the Ministry of Food and Drug Safety (MFDS) posted a revised version of the "Medical Device Adverse Event Report Guidelines" reflecting the revision of the standard code for medical device abnormalities and the frequently used standard code case. The medical device safety information management system is briefly as follows.1. If the medical device handler recognizes that death o..