• 2022-10-25 06:47:43

MDCG 2022-14 is aimed to propose solutions to improve the efficiency of application of the regulatory requirements, rather than reducing, avoiding or removing requirements, in particular in relation to safety.

• 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.

• 2022-09-27 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 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).

• 2022-05-26 14:21:34

On March 29, 2022, the Vietnamese MOH hosted a virtual conference to provide clarity to the new Price Declaration Process and announced the establishment of a new online portal for license holders to declare prices. Accordingly, all medical devices must publish the price in the DMEC website before placing the product in the Vietnam market, effective from April 1st, 2022.

• 2022-05-26 13:49:52

Screening and inspection of the importation of medical devices are being carried out at the main entry points of malaysia. This is one of the mechanisms to curb the activities of importing medical devices without a valid license, registration or authorization.

• 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.