• 2022-10-25 03:59:10

PFDA announced that alcohol swab product registrations will be transferred to the Center for Drug Regulation Research (CDRR). In the same month, PFDA also published a circular that aims to provide guidelines on the use of the FDA eServices Portal System for LTO applications of retailers of Medical Devices.

• 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.

• 2022-09-27 09:03:07

The pandemic has exposed supply chain vulnerabilities and issues in the medical device supply chain that were once insignificant. In this article, we compile the industry’s best practices towards achieving sustainability and resilience in the medical supply chain.

• 2022-09-27 07:39:04

In order for Thai FDA's quality control to conquer approval certificate issuance ratio, Thai FDA respectively announced a new E-Submission procedures governing Listing Medical Device, Notified Medical Device, and Licensed Medical Device applications (with exemption of class 1 auto approval), which has been effective since 1st August 2022.

• 2022-09-27 07:07:49

The Food and Drug Administration (FDA) established a new regulatory category for over-the-counter (OTC) hearing aids. The new policy will redefine OTC hearing aids and change the current rules as well as modify the obsolete old rules. FDA believes this method will ensure the OTC hearing aids with innovative technology provide reasonable safety and effectiveness, while promoting public health.

• 2022-09-27 06:12:22

The Vietnam Ministry of Health released Circular No. 05/2022/TT-BYT on August 1, 2022, detailing a number of articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021, on the management of medical devices.

• 2022-06-30 11:51:47

Given the return and the increased popularity of in-person medical exhibitions, Qualtech has taken the opportunity to provide you with a sneak peek of the innovative medical device trends to be observed in ASEAN’s upcoming big medical exhibitions and fairs. This includes, among other fields, wearable technology, augmented reality for surgeon training and pre-operation planning, as well as virtual reality surgery with robotic and artificial intelligence assistance.

• 2022-06-29 02:30:03

The termination of Thai FDA's "Pre-Submission" resulted in the establishment of a new route to determine product risk classification and medical device grouping via the E-submission system.

• 2022-06-29 01:41:00

The TGA has given a presentation about the evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims in the Australasian Society for Biomaterials and Tissue Engineering (ASBTE) Conference 2022. This presentation provided manufacturers and sponsors general insights on the subject of medical devices with anti-viral or anti-microbial claims before the device inclusion in the Australian Register of Therapeutic Goods (ARTG).