• 2022-06-29 02:17:39

In April 2020, the Medical Device Authority (MDA) has issued a new Guidance Document regarding the classification of Rehabilitation, Physiotherapy, and Speech Therapy Devices (MDA/GD/0061). This document guides the manufacturers and authorised representatives on classifying rehabilitation, physiotherapy, and speech therapy as medical devices.

• 2022-06-29 02:14:40

MDCG 2022-6 provides clarifications on the concept of ‘significant changes in the design and intended purposes’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC (IVDD) and that are placed on the market or put into service after 26th May 2022 during the transition period.

• 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 01:53:45

NMPA has made 3 important announcements on issuing the List of Medical Devices Prohibited from Contract Manufacturing (No. 17 of 2022), the Quality Agreements of Contract Manufacturing Medical Devices (No. 20, 2022), and on Matters Concerning the Implementation of the <Measures for the Supervision and Administration of the Production of Medical Devices> and the <Measures for the Supervision and Administration of the Operation of Medical Devices> (No. 18 of 2022), which have been summarized in our article below.

• 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.

• 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 14:17:56

The US FDA offers manufacturers an opportunity to interact with FDA's experts to speed up the necessary processes for breakthrough medical devices to enter the US market. As a result, manufacturers with breakthrough medical devices have several benefits in the premarket review phase and a prioritized submission review.