malaysia mda releases public comment draft for change notification on registered medical devices

Malaysia MDA Releases Public Comment Draft For Change Notification on Registered Medical Devices

On 6 April 2022, Malaysia’s Medical Device Authority (MDA) released draft guidance for change notification on registered medical devices. The draft guidelines are open for stakeholder comments until 20 April 2022. 

This document provides guidance to determine the correct categories of changes to continue importing, exporting, or placing registered medical devices on the market.

This fourth edition (which is open for comments) introduces the following changes:

  • Addition of Section 5.8 – Changes to Medical Devices
  • Changes to Section 6.0 – Notification Process
  • Changes to Section 7.0 – Requirement for Change Notification
  • Changes to Section 8.0 – Turn Around Time
  • Addition of Section 9.0 – Grace Period of Supply
  • Changes on Annex E – Application of Change Notification Flowchart

Other minor changes introduced in this draft version of the guidance are as follows:

  • The definition of a single application and multiple application
  • A clarification of the types of changes that require the registration holders to apply for new registration.
  • Addition of documents to be submitted for each category and type of change.
  • Examples that clarify the types of change

This amendment or fourth edition of MDA/GD/0020 will reduce time as multiple submissions are allowed. Additionally, it provides a clear explanation and example to avoid confusion about the changes to the EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR).

For more information, see the draft guidance on Medical Device Product Grouping.

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