Malaysia: MDA Released Second Edition Guidance Documents for Medical Gas System-Requirements for Registration February 21, 2023
Malaysia: MDA Released Fifth Edition Guideline Documents for Drug-Medical Device and Medical Device-Drug Combination Products January 31, 2023
Malaysia: MDA Issued First Edition Guideline Document on How to Submit An Application for Registration of A Refurbished Medical Device January 25, 2023
Malaysia: Draft guidance for requirements on certificate application of CFS, MC and CFS EO medical devices January 12, 2023
Malaysia: Keeping up with the Malaysian MDA Latest Regulatory Information and Activities January 11, 2023
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