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SINGAPORE: COVID-19 TEST KITS AUTHORIZED FOR PROFESSIONAL AND SELF-USE IN SINGAPORE — AUGUST/SEPTEMBER 2023

SINGAPORE: COVID-19 TEST KITS AUTHORIZED FOR PROFESSIONAL AND SELF-USE IN SINGAPORE — AUGUST/SEPTEMBER 2023

  • 2023-08-23 05:30:31

Effective July 1, 2023, COVID-19 diagnostic tests for professional use and self-test kits that were previously authorized under the Pandemic Special Access Route (PSAR) should now be registered through full-fledged product registration. In addition, validation requirement documents for each product type for professional use only and self-test kits were also issued by HSA.

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USA: NEW STANDARDS RECOGNITION TO SUPPORT INNOVATION IN MEDICAL DEVICE STERILIZATION — AUGUST/SEPTEMBER 2023

USA: NEW STANDARDS RECOGNITION TO SUPPORT INNOVATION IN MEDICAL DEVICE STERILIZATION — AUGUST/SEPTEMBER 2023

  • 2023-08-23 05:04:48

The US FDA has taken a significant step towards enhancing medical standards and knowledge sharing for improved healthcare. They have recently updated their Recognized Consensus Standards database to grant full recognition to ISO 22441:2022, a pivotal sterilization standard. Additionally, the FDA has included two Technical Information Reports (TIR), namely AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020, demonstrating their dedication to advancing medical practices and spreading knowledge in the healthcare field.

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QT ACTIVITY: SUMMARY OF QUALTECH'S ACTIVITY – JULY/AUGUST 2023

QT ACTIVITY: SUMMARY OF QUALTECH'S ACTIVITY – JULY/AUGUST 2023

  • 2023-07-21 03:58:08

Qualtech hosted a talk by Dr. Huang Wen-Chien on the evolution of minimally invasive lung cancer treatment. The advancements discussed included surgical tools, non-surgical techniques, and video-assistive technology. Qualtech also offers comprehensive Clinical Evaluation Report (CER) services to assist with medical device registration, drawing upon expertise in biomedical engineering and molecular biology to deliver high-quality reports for various regions.

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MALAYSIA: MDA announced the Third edition on Guidance on Medical Face Mask and Respirator – JULY/AUGUST 2023

MALAYSIA: MDA announced the Third edition on Guidance on Medical Face Mask and Respirator – JULY/AUGUST 2023

  • 2023-07-21 02:46:26

The Medical Device Authority (MDA) published the Third Edition Guidance Document, "On Guidance on Medical Face Mask and Respirator", on May 19, 2023. This document is intended to give clarity on medical face masks and respirators regulated by the Medical Device Act (Act 737). This document applies to establishments, healthcare facilities, and the general public who deal with medical face masks and respirators.

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MALAYSIA: MDA ANNOUNCED THE TRANSITION PERIOD FOR THE IMPLEMENTATION OF ELECTRONIC MEDICAL DEVICE REGISTRATION CERTIFICATE –  JULY/AUGUST 2023

MALAYSIA: MDA ANNOUNCED THE TRANSITION PERIOD FOR THE IMPLEMENTATION OF ELECTRONIC MEDICAL DEVICE REGISTRATION CERTIFICATE – JULY/AUGUST 2023

  • 2023-07-21 02:38:16

The MDA announced a transition period for the implementation of electronic medical device registration certificates on May 22nd, 2023. This announcement is intended to provide information on the use of Electronic Medical Device Registration certificates, which will be fully implemented on January 1st, 2024, and no more physical medical device registration certificates will be issued by MDA.

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