Malaysia: Announcement On Registration Of COVID-19 Test Kits That Have Been Applied Via Conditional Approval And Special Access January 10, 2023
Malaysia: MDA Issued Fourth Edition Guidance Document “Change Notification for Registered Medical Device” (MDA/GD/0020) November 30, 2022
MDA Issued Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026) November 29, 2022
Malaysia: MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) October 2, 2022
Malaysia: Guideline for Registration of Orthopoxvirus (Monkeypox) IVD Test Kits by MDA September 29, 2022
Malaysia: MDA Released Two New Guidance Documents on Harmonized Risk Classification of Medical Devices and Borderline Products in ASEAN September 12, 2022
Malaysia: Enforcement Activities Carried Out By The MDA During The Participation In The Pangea XV 2022 Operation August 24, 2022
Malaysia: Full Enforcement Announcement of Medical Device Regulations (Responsibility & Establishment) 2019 July 11, 2022
Malaysia: Medical Device Authority Releases Fifth Edition of Requirements for Labelling of Medical Devices July 11, 2022
Malaysia: MDA Provides Transition Period For Compliance With The Requirements Of Labelling Of The Medical Devices (MDA/GD/0026, Fifth Edition) July 6, 2022
Malaysia: Medical Device Authority (MDA) Amends Policy for Control over Orphaned, Obsolete and Discontinued Medical Devices June 23, 2022
Malaysia: Medical Device Authority (MDA) Improves the Policy for Control of Medical Device Refurbishment June 21, 2022