MALAYSIA: Revision to the Requirements for Foreign Manufacturer Contact Details in the Requirement for Labelling of Medical Devices (MDA/GD/0026) – June/July 2026

• 2026-07-27 03:35:56

The Medical Device Authority (MDA) of Malaysia has published a revised guidance document, MDA/GD/0026: Requirements for Labelling of Medical Devices. This revision updates the requirements for inclusion of foreign manufacturer contact details on medical device labels. The revised requirements took effect on 22 May 2026.

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QT ANALYSIS: Quality Management System Requirements for Foreign Manufacturers – December 2022/January 2023

• 2022-12-27 10:11:55

A Quality Management System (QMS) is used by a company or manufacturer as a set of policies, procedures, and processes. It provides a constructive handling and coordination of a business by continual improvements in effectiveness and efficiency. In this article, the QMS requirements for medical device manufacturer, company or organization on different countries will be explored.

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