• 2024-09-17 05:57:50

Australia's TGA has issued two new guidance on software-based medical devices. Sponsors must comply with the new classification rules with the transition period ending by November 1, 2024. Additionally, the TGA clarified which software products are subject to regulation, providing clear guidelines for industry.

• 2023-11-20 02:19:57

This guidance provides clarifications on which specific regulatory considerations apply when the hardware or hardware component are classified as a medical device or an accessory to a medical device.

• 2023-09-27 07:05:52

The Japanese MHLW has issued Q&A on Software Cybersecurity that was newly added to the Essential Principle

• 2023-07-21 02:14:29

The US FDA recently issued an updated guidance aimed at providing comprehensive information on the recommended documentation for premarket submissions. The purpose of this guidance is to assist the FDA in evaluating the safety and effectiveness of device software functions.

• 2023-05-24 07:21:35

The Japanese MHLW has issued a complimentary notice to explain further about cybersecurity of the Essential Principles Requirements.

• 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.

• 2022-10-25 03:34:27

To provide a better understanding of the classification of medical-related software devices, TFDA has updated the existing guidance with some examples of SaMD and non-SaMD software. This article provides you with a quick insight into defining medical-related software devices.

• 2022-10-24 09:56:11

TFDA has recently announced a specific product registration guidance for AI/ML-based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software. Through the application of AI and ML-based technologies in detective or diagnostic medical devices, these kinds of products could be essential for medical personnel by decreasing required reading time with better diagnostic performance.

• 2022-06-29 01:29:59

Recently, software technology has made significant advances and has been used considerably more frequently for medical purposes. It can drive itself to infer a clinical judgment in addition to serving as a message informant. The number of software-based medical devices that are currently on the market has significantly increased as a result of such software improvements. Therefore, it is important to monitor patient safety appropriately.

• 2022-04-27 11:32:12

Concerning the rapid development of Artificial Intelligent/Machine Learning-Based SaMD, TFDA has updated the related guidance that was initially announced in 2020. The latest requirements are summarzied in this article.