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MALAYSIA: MDA/GD/0005 about General Medical Device Grouping - February/March 2024

MALAYSIA: MDA/GD/0005 about General Medical Device Grouping - February/March 2024

  • 2024-03-01 07:14:04

The Medical Device Authority (MDA) published the Second edition Guidance Document, "Guidance on General Medical Device", on January 30, 2024. This guidance document provides aims to help determine the appropriate grouping for medical devices in the medical device registration application. This document applies to all products that fall within the definition of medical device that has been specified in the Guidance Document: Definition of Medical Device (MDA/GD/0006) excluding In-vitro Diagnostic Medical Device.

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USA: Quality Management System Regulation Updates and FAQs: Final Rule Amending the Quality System Regulation - February/March 2024

USA: Quality Management System Regulation Updates and FAQs: Final Rule Amending the Quality System Regulation - February/March 2024

  • 2024-03-01 06:21:15

The FDA has released a final rule amending regulation amending the current good manufacturing practice (CGMP) guidelines for medical devices under the Quality System (QS) Regulation. This rule entails an amendment to 21 CFR 820, adopting the quality management system standards outlined in the ISO 13485:2016, established by the International Organization for Standardization (ISO).

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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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