In December 2025, Malaysia’s Medical Device Authority (MDA) published for public comment its draft First Edition of Guidance on the management of changes to registered medical devices. This guidance is an important milestone in how modifications to registered medical devices will be governed under the Malaysian Medical Devices Act 2012 (Act 737).
The Draft Guidance is open for stakeholder comment and will incorporate updated principles, classification categories, reporting obligations, and pathways for managing changes to registered medical devices.
Changes to registered devices resulting from post-market issues or new re-registration requirements are also within the scope of the Draft Guidance. Key components include a new risk-based framework to differentiate between significant and non-significant changes and their related submission pathways, flowcharts to facilitate decision-making, and provisions for Software as Medical Device (SaMD) and Unique Device Identifier (UDI-DI) triggers.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.