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
Malaysia: MDA Released the Second Edition Guidance Document MDA/GD/0005: General Medical Device-Grouping March 13, 2024
Malaysia: Draft Guidance Document: Placement of HIV Self-Test (HIVST) Kit in Malaysia Market March 4, 2024
Malaysia: MDA Releases Guidance Document MDA/GD/0067: Enhancing Post Market Information Exchange for ASEAN Member States February 20, 2024
Malaysia: MDA Released Guidance Document MDA/GD/0066: Importation of Medical Device for Personal Use February 20, 2024
Malaysia: Updated Information on the Surveillance Report of Implantable Medical Devices in Malaysia January 3, 2024
Malaysia: MDA Issued Two Updated Guidance Documents on Harmonised Classification and Borderline Products in ASEAN December 19, 2023
