The Medical Device Authority (MDA) of Malaysia has published a new guidance document, Change Management for Registered Medical Devices (MDA/GD/0072). This document outlines the general principles, updated categorization, reporting procedures, and alternative pathways for managing changes to registered medical devices. With the updates, the document employs a risk-based approach with a few illustrative examples (Flowchart). The Change Management (CM) process applies to any changes to a registered medical device or updates related to post-market issues including reportable incidents and field corrective actions, or information updates or documents required in preparation for re-registration.
A. Categorisation of Changes
Changes to a registered medical device may be categorized as either significant or non-significant, depending on the extent to which the changes may impact the safety and/or performance of the device as shown in the table below:
| Significant Change | Non-Significant Change |
| Introduce risks to the patient and / or user that were not previously identified in the risk management file, Increase the probability of occurrence of existing hazards, Modify the presentation of existing or new risks to the user, including those arising from labelling changes or new indications for use. May include but are not limited to: The manufacturing process, facility, or equipment, The manufacturing quality control procedures, including methods, tests, reference standards, or procedures used to control the quality, purity, and sterility of the device or the materials used in its manufacture, The design of the device, including its performance characteristics, principles of operation, and specifications of materials, energy source, software, or accessories. | Any change that has little or no potential to affect the safety and/or performance of the medical device. |
B. Flowcharts for Categorisation of Change
The overall change management process under MDA/GD/0072 is illustrated in the flowchart in Figure 1. This flowchart outlines the general categories of changes and provides practical guidance to support manufacturers in assessing whether a change may affect the safety and/or performance of a medical device. In addition, the guidance document includes Flowcharts A–G as described in the table below, which provide detailed decision-making pathways for specific types of changes and assist manufacturers in determining the appropriate change category and regulatory requirements as shown in Figure 2. Applicants should refer to the relevant flowchart when assessing proposed changes to registered medical devices.
| Flowchart | Changes |
| Main Flowchart | General Type of Changes to Medical Devices and In Vitro Diagnostic (IVD) Medical Devices |
| Flowchart A | Changes in Manufacturing Processes, Facility and/or Quality Management System (including QC) for Medical Devices and In Vitro Diagnostic (IVD) Medical Devices |
| Flowchart B | Changes in Design for Medical Devices and In Vitro Diagnostic (IVD) Medical Devices |
| Flowchart C | Changes to Sterilization Facility and its Process |
| Flowchart D | Changes to Software for Medical Devices |
| Flowchart E1 | Changes in Materials for Medical Devices |
| Flowchart E2 | Changes in Materials for In Vitro Diagnostic (IVD) Medical Devices |
| Flowchart F | Changes to Labelling of Medical Devices and In Vitro Diagnostic (IVD) Medical Devices |
| Flowchart G | Changes to Registered Medical Devices and In Vitro Diagnostic (IVD) Medical Devices registration information |
C. Reporting of Changes
Any changes classified as Significant Changes must be reported to and approved by MDA prior to implementation. Affected medical devices can only be placed on the market after MDA approval has been obtained. Non-Significant Changes generally do not require prior reporting; however, certain categories of non-significant changes may still require notification to MDA together with relevant supporting documentation as stated in the guidance document. A recommended approach for reporting various types of changes is summarized in the table below:
| Type of Changes | Reporting Pathway |
| 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. |
D. Turn-Around Time (TAT)
The turn-around time (TAT) for the evaluation of each CM application made by the manufacturer/AR upon submission of a complete application form together with all required supporting documents is outlined below:
| Application Type | Significant Change | Non-Significant Change |
| Single Application for Single Type of Change | 10 working days | No TAT, as the change may be implemented immediately. |
| Single Application for Multiple Type of Change | Until 45 working days | |
| Multiple Application | Until 45 working days |
Manufacturers are required to assess the impact of any modification made to a medical device to determine whether it may affect the device's safety, performance, effectiveness, quality management system compliance, or regulatory compliance. This assessment serves as the basis for determining the appropriate change category and reporting pathway, while ensuring the continued safety and performance of the medical device. As such, manufacturers and Authorised Representatives (ARs) are expected to remain informed of current regulatory requirements and guidance to ensure changes are assessed and managed in accordance with MDA requirements.
Stay ahead of Malaysia's evolving medical device regulations. Contact Qualtech regulatory experts for support in assessing and managing change submissions in compliance with MDA requirements.
Clarification through Visuals
Figure 1 Overview Flowchart of Types of Changes
Figure 2 Flowchart A to G - Categorisation of Change Types
Reference
Publication of First Edition Guidance Document Change Management for Registered Medical Devices