• 2022-07-26 09:41:26

The TGA has released version 3.1 of its latest guideline for the clinical evidence for medical devices. The purpose of this guideline is to allow both industry and TGA to support sponsors and manufacturers to collect, compile and present clinical evidence under regulatory requirements as well as to inform on how TGA assesses clinical evidence.

• 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 03:18:32

The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing. The concept comes from the Medical Device Innovation Consortium (MDIC), which assesses the capability and performance of key business processes using a maturity appraisal model tailored to the medical device industry. The overall stated goal is to enhance the quality processes and to improve the overall medical device quality, as to ultimately ensure better patient treatment outcomes.

• 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 02:24:35

The Malaysia Medical Device Authority (MDA) released the 2nd Edition of Guidance on The Rules of Classification for General Medical Devices MDA/GD/0009 on May 9, 2022.

• 2022-06-29 02:11:11

MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.

• 2022-06-29 02:03:22

China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 11-15, 17, as well as 22 of the Category of Medical Devices.

• 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).

• 2022-06-29 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.

• 2022-05-31 02:38:03

The COVID-19 epidemic has undoubtedly boosted the healthcare industry digitization worldwide. Personal medicine, telemedicine, genomics, and wearables are predicted to increase significantly over the next half decade thanks to artificial intelligence (AI), extended reality (XR), cloud computing, and the internet of things (IoT). In the face of this trend, there are several opportunities and problems particular to the Asian medical device industry. In this article, we examine the general situation of the Asian medical device industry as well as the Chinese, Japanese, and ASEAN markets in further detail.