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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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China: Announcement on the Issuance of Guidelines for the Preparation of Annual Self-Inspection Reports of the Medical Device Quality Management System (No. 13 of 2022) – May, 2022

China: Announcement on the Issuance of Guidelines for the Preparation of Annual Self-Inspection Reports of the Medical Device Quality Management System (No. 13 of 2022) – May, 2022

  • 2022-05-26 13:11:53

NMPA has organized and revised the “Guidelines for the Compilation of the Annual Self-Inspection Report of Medical Device Quality Management System”, which has been promulgated and shall come into force on May 1, 2022. The Guidelines for the Compiling of the Annual Self-Inspection Report of Quality Management System of Medical Device Manufacturers issued by NMPA (No. 76 of 2016) previously shall be abolished at the same time.

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