Malaysia: MDA released Circular Letter No. 1 Year 2023: Permission for HIV Self-Test Kits Placement in the Malaysian Market September 6, 2023
Malaysia: Draft Regulation for Public Comments: Importation of Medical Device for Re-Export September 6, 2023
Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use August 14, 2023
Transition Period for the Registration of COVID-19 Test Kits with Exemption from Compliance Process by the CAB July 20, 2023
Malaysia: MDA’s Approach to Expired EC Certificates for New Registration and Re-Registration of Medical Devices July 3, 2023
Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS June 28, 2023
Malaysia: MDA Announced Enforcement of Payment for all Subsequent Notification Clinical Research Use in MeDC@St 2.0+ June 8, 2023
Malaysia: MDA Released Third Edition Guidance Document on Medical Face Mask and Respirator (MDA/GD/0033) May 24, 2023
Malaysia: MDA Announced Transition Period for the Implementation of Electronic Medical Device Registration Certificate May 10, 2023
Malaysia: MDA Announced Withdrawal of Incomplete Medical Device Registration (New and Re-Register) and Change Notification Application March 27, 2023
Malaysia: MDA Issued Second Edition Guidance Document (MDA/GD/0061) Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device March 24, 2023
Malaysia: MDA Issued the First Edition Guidelines on “Notification of Custom-Made Medical Device” (MDA/GD/0064) March 13, 2023
