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QT ANALYSIS: Innovative Medical Device Trends To Be Observed in the Upcoming Medical Fairs in the Asia-Pacific Region – June, 2022

QT ANALYSIS: Innovative Medical Device Trends To Be Observed in the Upcoming Medical Fairs in the Asia-Pacific Region – June, 2022

  • 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.

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USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

  • 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The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing.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.

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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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MDR: MDCG 2022-6 - Guidance on Significant Changes Regarding the Transitional Provision under Article 110(3) of the IVDR – June, 2022

MDR: MDCG 2022-6 - Guidance on Significant Changes Regarding the Transitional Provision under Article 110(3) of the IVDR – June, 2022

  • 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.

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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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