Malaysia: Issuance of Second Edition Guidance on HIV Self-Test Kit (HIVST) Placement February 6, 2025
Malaysia: Draft Guidance Document for Public Comments: Importation of Medical Device for Personal Use – Second Edition February 4, 2025
Medical Device Authority (MDA) Shared 2025 Plans via Facebook Live Event on January 14, 2025 January 24, 2025
Malaysia: Managing Obsolete and Discontinued Medical Devices in Healthcare Facilities November 25, 2024
Malaysia: MDA’s Approach to Expired EC Certificates and Self-Declared for New Registration and Re-Registration of Class B IVD Medical Devices August 28, 2024
Malaysia: MDA Announced The Implementation Of Electronic Establishment License Certificates Starting June 5, 2024 June 10, 2024
Malaysia: Revocation Of Medical Device Authority (MDA) Circular No. 1/2022: Exemption Of The Compliance Assessment Process By Conformity Assessment Bodies (CAB) For The Registration Of COVID-19 Test Kits June 10, 2024
Malaysia: MDA Announced the Implementation of the One License Per Establishment Role Policy Starting July 1, 2024 June 10, 2024
Malaysia: Draft on Guidance Documents: Change Notification For Registered Medical Device – Fifth Edition June 4, 2024
Malaysia: Draft For Public Comment on Guidance Documents: Change Notification For Registered Medical Device – Fifth Edition May 28, 2024
Malaysia: Encouragement to Submit Medical Device Re-Registration Applications One Year before the Certificate Expiration Date May 21, 2024
Malaysia: Medical Device Authority (MDA) Released Circular Letter No. 1/2024: Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions May 8, 2024
Malaysia: MDA Announced Regulation Governing the Implementation of the Policy of One License for Each Establishment Role April 23, 2024
Malaysia: Cancellation of the Regulation Governing the Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for the Registration of COVID-19 Test Kits April 23, 2024
