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 01, 04, 07-10, 19, as well as 21 of the Category of Medical Devices.
More The Center for Medical Device Evaluation (CMDE) has formulated “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>".
More 18 medical device industry standards have been approved and are now published. The number, name, scope of standards and date of implementation can be found in the attachment.
More According to the De Novo Classification request from the respective manufacturers, the US FDA reviewed the request for the following devices, Intravascular Bleed Monitor and Non-Implanted Electrical Stimulation Devices for Management of Premature Ejaculation. As a result, both types of products are now classified as Class II products rather than belong to products of Class III.
More 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.
More In the beginning of 2022, the Therapeutic Goods Advertising Code 2021 came into effect. Six month transition period were given, and sponsors and manufacturer were allowed to either follow the 2018 Code or the 2021 Code until 30th June 2022. From 1 July 2022 onwards the option of complying with the 2018 Code yet no longer applies.
More The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing.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.
More 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).
More 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.
More
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.
MoreWe collect your browsing history through cookies to understand how you use our website to analyze and improve your experience. By continuing to use our website, you accept our use of cookies.
