• 2025-01-22 03:51:46

Medical Device Cluster (MDC) is rolling out the pilot run for the Change Management Program (CMP) for Software as Medical Device (SaMD), also known as a Standalone medical mobile application, including Machine Learning-Enabled SaMD. The program is voluntary and incorporated into HSA's existing Premarket Product Registration and Change Notification process. With effect from 4 December 2024, HSA also published new guidance document (GN-37) for the program.

• 2024-12-16 07:05:36

Thai FDA has updated its guidance on the registration of Software as a Medical Device (SaMD) and Artificial Intelligence (AI) medical devices. Key revisions include new requirements for establishment licensing, compliance with advertising regulations, and enhanced cybersecurity measures. The updated guidance offers stakeholders a clear framework for classification criteria, document preparation, and post-market responsibilities.

• 2024-10-10 08:46:48

HSA's Medical Devices Cluster has released a draft of Guidance on Change Management Program (CMP) for stakeholders with consultation period from 26 August 2024 to 21 October 2024. The new optional regulatory pathway aims to accommodate the rapid iterative nature of SaMD changes. This guidance explains on the CMP definition, scope, eligibility, requirements, and process. The guidance also introduces the concept of 'Pre-specified' changes. Feedback on the guidance draft can be sent to HSA through email by using prescribed feedback form.

• 2023-02-23 01:23:58

Thai FDA has published a guidance, which aims to assist the justification status of Software as Medical Device (SaMD) as well as its risk classification for Thai FDA registration.

• 2022-07-26 11:13:22

MHLW announces evaluation items for medical devices that use new technology to speed up the approval process. This time evaluation items for Breast Cancer Diagnosis Device and SaMD with Behavior Change were announced.

• 2021-08-26 12:40:18

HSA released a draft guideline for consultation on the classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software (CDSS) based on similar guidance released by IMDRF for Software as a Medical Device (SaMD) This guideline provides information on the qualification of CDSS as MDs as well as the regulatory approach for such.

• 2021-08-02 06:36:08

On June 30th, Qualtech and ISS AG jointly hosted an online event informing far more than 100 different medical device manufacturers from all around the globe about China’s New Regulations. Qualtech’s team thereby detailed the important updates that the new RSAMD will bring, including the new obligations for product registrants under the nationwide adopted MAH system.