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

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: Updated in Conformity Assessment Body (CAB) and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment By Way of Verification (MDA/GD/0068) and (MDA/GD/0070) – September/October 2025

MALAYSIA: Updated in Conformity Assessment Body (CAB) and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment By Way of Verification (MDA/GD/0068) and (MDA/GD/0070) – September/October 2025

  • 2025-10-27 03:24:28

The Malaysia Medical Device Authority (MDA) has published the latest Conformity Assessment Body (CAB) guide and establishment guide to medical device registration submission in MeDC@St for Conducting Assessment by Way of Verification process, which includes updates on additional recognized regulatory authorities and revised verification procedures to help establishments streamline registration and ensure regulatory compliance.

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