Newsletter

QT Activity: Qualtech's Year-end Updates 2023 – January/February 2024

QT Activity: Qualtech's Year-end Updates 2023 – January/February 2024

  • 2024-01-26 07:26:23

Reflecting on 2023, Qualtech experienced a dynamic and transformative year marked by regulatory webinars and the establishment of a new office in Korea. Amid challenges and celebrations, we fortified our commitment to excellence, setting the stage for continued growth and even greater achievements in the future. Join us in revisiting the highlights that shaped our journey.

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INDONESIA: Testing and Certification for Telecommunication Medical Devices –January/February 2024

INDONESIA: Testing and Certification for Telecommunication Medical Devices –January/February 2024

  • 2024-01-26 06:28:31

Telecommunication technologies or devices in Indonesia, including telecommunication medical devices, should apply for Certificate of Telecommunication Device. In order to comply with this requirement at this moment, Indonesia MoH encourages manufacturer of medical devices with Bluetooth and RFID feature to voluntarily submit either Certificate of Telecommunication Device or Declaration Letter confirming the proposed product will apply for this certification during pre-market application.

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MALAYSIA: Harmonised Borderline Product in ASEAN  –January/February 2024

MALAYSIA: Harmonised Borderline Product in ASEAN –January/February 2024

  • 2024-01-26 05:18:26

The Medical Device Authority (MDA) published a second edition guidance document on “Guidance on Harmonised Borderline Product in ASEAN" on December 23, 2023. This guidance document provides a list of borderline products, whether they are medical devices or non-medical devices, based on their intended purpose as claimed by the manufacturer, which is harmonised in ASEAN. This guidance document will be updated on a yearly basis to reflect the latest decisions of the ASEAN Medical Device Committee (AMDC).

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MALAYSIA: Harmonised Classification of Medical Device in ASEAN –January/February 2024

MALAYSIA: Harmonised Classification of Medical Device in ASEAN –January/February 2024

  • 2024-01-26 05:03:01

The Medical Device Authority (MDA) published Second edition Guidance Document, on “Guidance on Harmonised Classification of Medical Device in ASEAN”, on December 12, 2023. This guidance document provides the harmonised list of risk classification of medical devices including in-vitro diagnostic (IVD) medical devices based on their intended use/ purpose as claimed by the manufacturer.

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