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MALAYSIA: Introduction of the Automated Re-Registration Route in MeDC@St 2.0+ for Streamlined Market Access and Continuous Supply of Medical Devices – July/August 2026

MALAYSIA: Introduction of the Automated Re-Registration Route in MeDC@St 2.0+ for Streamlined Market Access and Continuous Supply of Medical Devices – July/August 2026

  • 2026-08-25 07:50:09

The Medical Device Authority (MDA) of Malaysia has announced the new Automated Re-Registration Route within the MeDC@St 2.0+ platform, effective from 13 July 2026. This initiative aims to support continuous product availability, reducing administrative workload, and improving regulatory efficiency while maintaining compliance with existing MDA requirements.

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MALAYSIA: MDA Regulatory Updates - Publication of Third Edition Guidance on Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application – April/May 2026

MALAYSIA: MDA Regulatory Updates - Publication of Third Edition Guidance on Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application – April/May 2026

  • 2026-05-27 09:53:25

The Medical Device Authority (MDA) has published the latest edition of Import and/or Supply of Unregistered Medical Devices Under Special Access Exemption Application, MDA/GD/0043, which outlines the eligibility of personnel authorized to apply for the exemptions, specifies the procedures for notification, applicant responsibilities, and use of unregistered medical devices. The document is intended to facilitate timely access to medical devices for specific needs in healthcare settings.

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