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MALAYSIA:  MDA Introduces New Guidance Document MDA/GD/0061: Classification of Rehabilitation, Physiotherapy And Speech Therapy Device – June, 2022

MALAYSIA: MDA Introduces New Guidance Document MDA/GD/0061: Classification of Rehabilitation, Physiotherapy And Speech Therapy Device – June, 2022

  • 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.

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China: NMPA's 3 Important Announcements Regarding MDs Prohibited from Contract Manufacturing, Quality Agreements of Contract Manufacturing, and the Implementation of Measures for the Supervision of Production and Operation – June 2022

China: NMPA's 3 Important Announcements Regarding MDs Prohibited from Contract Manufacturing, Quality Agreements of Contract Manufacturing, and the Implementation of Measures for the Supervision of Production and Operation – June 2022

  • 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.

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AUSTRALIA: TGA Evidence Expectations for Medical Devices or Surfaces with Anti-Viral or Anti-Microbial Claims – June 2022

AUSTRALIA: TGA Evidence Expectations for Medical Devices or Surfaces with Anti-Viral or Anti-Microbial Claims – June 2022

  • 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).

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AUSTRALIA: Regulations of Software-Based Medical Devices – June 2022

AUSTRALIA: Regulations of Software-Based Medical Devices – June 2022

  • 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.

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QT ANALYSIS: The Asian Medical Device Industry Beyond the Pandemic

QT ANALYSIS: The Asian Medical Device Industry Beyond the Pandemic

  • 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.

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VIETNAM: Training Conference on Declaration and Publicization of Medical Device Prices According to the Provisions of Decree 98/2021/ND-CP – May, 2022

VIETNAM: Training Conference on Declaration and Publicization of Medical Device Prices According to the Provisions of Decree 98/2021/ND-CP – May, 2022

  • 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.

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USA: The Medical Device Breakthrough Devices Program in the USA – May, 2022

USA: The Medical Device Breakthrough Devices Program in the USA – May, 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.

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