Andaman Medical Regulatory Affairs Update Malaysia

Malaysia: Draft For Public Comment on Guidance Documents: Change Notification For Registered Medical Device – Fifth Edition

On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020.

The main highlights from this draft guidance document are as follows:
• Establishments are required to identify the appropriate application type, either Single Application or Multiple Application, as outlined in Table 3 of Section 6.2. This table provides a comprehensive overview of the requirements for both application types.
• Additionally, Establishments can refer to Annex D and Annex E for flowcharts illustrating the Single Application and Multiple Application change notification processes, respectively. Explanatory Notes for each application type are provided in Table 7 and Table 8.

This draft is open for comment and feedback. An establishment may submit their feedback using the attached public comment form to before 3rd June 2024.

The announcement by the MDA can be accessed here.

For further information on the draft guidance document, please refer to this link.

If you have any queries about this draft guidance, please contact us at or click the button below.

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