Medical Device Authority (MDA) has published a guidance document  “Change Management for Registered Medical Devices’ for public comment. 

This guidance document will replace the existing MDA/GD/0020 Change Notification for Registered Medical Device and will be enforced concurrently with the launch of MeDC@St 3.0. This document outlines general principles, categorization, reporting, and alternative pathways for managing changes. It employs a risk-based approach with illustrative examples.

We would like to invite the industry and stakeholders to provide feedback on this draft guidance document. The public comment period for this draft guidance document is from 2nd-16th December 2025. Please submit your feedback using the attached public comment form to [email protected] before 16th December 2025.

 

This guidance document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following:

 

a) Medical Device Act 2012 (Act 737);  and

b) Medical Device Regulations 2012. 

 

To download guidance document, please download Attachment 1. To download feedback form, please download Attachment 2.

 

 

Prepared by: Policy & Strategic Planning Division

Uploaded by: Corporate Communication Division 

Date of upload: 3/12/2025