Regulatory Affairs Update: Malaysia

Malaysia: Draft 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On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows: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.

The announcement by the MDA can be accessed here: Guidance Documents Draft.

If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.

Sign up for our regulatory roundup delivered once a month to your inbox



Scroll to Top

Contact Us