On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows: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