The Medical Device Authority (MDA) has published the draft for comments of the First Edition Guidance Document titled “CHANGE MANAGEMENT FOR REGISTERED MEDICAL DEVICES”. This document outlines general principles, categorization, reporting, and alternative pathways for managing changes. It employs a risk-based approach with illustrative examples.
Read the full announcement to learn more: https://portal.mda.gov.my/index.php/announcement/1729-announcement-public-comment-first-edition-guidance-document-change-management-for-registered-medical-devices
Purpose of the Guidance Document
- To define the process for all registered medical devices under the Act 737, and outline key considerations for manufacturers when a device undergoes any changes or modifications.
- The document is intended to replace the existing guidance, Change Notification for Registered Medical Device (MDA/GD/0020), and will be enforced concurrently with the launch of MeDC@St 3.0.
- To provide clear guidance for stakeholders to handle changes to registered medical devices.
- The aim is to make sure any changes made to a registered medical device still follow Malaysian laws and regulations, so the device can continue to be sold safely in Malaysia.
Read the guidance document to review the draft in detail [PDF]
Key Highlights
Reporting of Changes
The document categorizes changes into 4 types of changes and defines the corresponding submission approaches.
Type of Changes | Submission Approaches |
Significant Change | Changes that require evaluation and approval by the MDA prior to implementation and before the device is placed on the market. |
Non-Significant Change- Notification Required | Changes that may be implemented immediately upon submission of complete documentation through MeDC@St. |
Non-Significant Change – Notification Optional | Changes that do not require submission; however, the manufacturer may submit a notification voluntarily. |
Non-Significant Change | Changes that do not require submission but must be fully documented within the manufacturer’s QMS and/or technical documentation. |
Flowchart System
The document provides detailed flowcharts, Annex A (main flowchart) and Annex B, a flowchart covering A to G, to help manufacturers systematically determine whether a modification (e.g., changes to manufacturing, design, materials, or software) is classified as Significant or Non-Significant, and what supporting documentation is required.
UDI-DI Triggers
The guidance specifies that changes to key elements like brand name, model, size, sterility, or critical warnings necessitate the assignment of a new Unique Device Identifier-Device Identifier (UDI-DI).
Bundling of Changes
Significant and non-significant changes that require notification submission in MeDC@St may be bundled for regulatory submission purposes, provided the changes meet the requirements outlined in this guidance.
Updates Before Re-Registration
Manufacturers are encouraged to update their device information and supporting documents via the Change Management module prior to submitting for re-registration. Only devices with fully updated and current information may proceed with re-registration.
Software as a Medical Device (SaMD)
A section on Predetermined Change Control Plans (PCCP) for SaMD is included. Any subsequent change to an approved PCCP must be submitted to the MDA via a change management application.
Public Comment Period
From 2nd December 2025 – 16th December 2025
Feedback should be submitted using the Public Comment Form (Borang Ulasan Umum Pembangunan Dokumen Panduan GD 2025)
Submission Instructions
- Submit completed forms to: guidancedocument@mda.gov.my
- Submission deadline: 16th December 2025
Applicable Laws and Regulations
This guidance document should be read in conjunction with the following:
- Medical Device Act 2012 (Act 737)
- Medical Device Regulations 2012
Implications to Clients
- Stakeholders are encouraged to review and provide feedback on the draft guidance document.
- This document outlines general principles, categorization, reporting, and alternative pathways for managing changes. It employs a risk-based approach with illustrative examples.
- Stakeholder input will contribute to the refinement and finalization of the guidance document.
Effective Date
To be announced upon final issuance of the guidance document.
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.
