MALAYSIA: MDA Regulatory Updates – Requirement of Labelling Guidance Document ＆ HSA Verification Approvals – February/March 2026

• 2026-04-01 07:01:44

The Medical Device Authority (MDA), Malaysia, announces two key updates for medical device registration. The latest labelling guidance introduces e-labelling requirements, while conformity assessments conducted by Singapore's Health Sciences Authority (HSA) are now recognized through a verification-based process. These updates aim to streamline registration and ensure compliance for medical devices in Malaysia.

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MALAYSIA: MDA Announced the New Guidance on Requirements for Labelling of Medical Devices – December 2022/January 2023

• 2022-12-27 05:37:15

The Malaysia Medical Device Authority (MDA) published the updated Sixth Edition Guidance Document, “Requirement for Labelling of Medical Device” (MDA/GD/0026), on November 21, 2022. MDA has made a few changes, respectively. MDA/GD/0026 is intended to assist manufacturers and authorized representatives with guidance on the content of medical device labelling. Labelling is used to both identify particular medical devices and to convey safety and performance-related information to patients or users of medical devices.

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MALAYSIA: Revision in the Guidance Document of Requirement For Labelling of Medical Devices – January, 2022

• 2022-01-26 10:39:04

Malaysia's Medical Device Authority (MDA) has published the Fourth Edition of its Guidance Document on Medical Device Labelling Requirements. This guidance document is beneficial in informing stakeholders about the additional requirements and materials that must be included in medical device labelling marketed in Malaysia.

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