MDA Released Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Products January 31, 2023
MDA Issued First Edition Guideline Document on How to Submit An Application for Registration of A Refurbished Medical Device January 25, 2023
Draft guidance for requirements on certificate application of CFS, MC and CFS EO medical devices January 12, 2023
Announcement On Registration Of COVID-19 Test Kits That Have Been Applied Via Conditional Approval And Special Access January 10, 2023
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
MDA Issued Second Edition Guidance Document “Licensing for Establishments” (MDA/GD/0027) October 2, 2022
MDA Released Two New Guidance Documents on Harmonized Risk Classification of Medical Devices and Borderline Products in ASEAN September 12, 2022
Enforcement Activities Carried Out By The MDA During The Participation In The Pangea XV 2022 Operation August 24, 2022
Full Enforcement Announcement of Medical Device Regulations (Responsibility & Establishment) 2019 July 11, 2022
