Transition Period for the Registration of COVID-19 Test Kits with Exemption from Compliance Process by the CAB July 20, 2023
Malaysia: MDA’s Approach to Expired EC Certificates for New Registration and Re-Registration of Medical Devices July 3, 2023
Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS June 28, 2023
Malaysia: MDA Announced Enforcement of Payment for all Subsequent Notification Clinical Research Use in MeDC@St 2.0+ June 8, 2023
Malaysia: MDA Released Third Edition Guidance Document on Medical Face Mask and Respirator (MDA/GD/0033) May 24, 2023
Malaysia: MDA Announced Transition Period for the Implementation of Electronic Medical Device Registration Certificate May 10, 2023
Malaysia: MDA Announced Withdrawal of Incomplete Medical Device Registration (New and Re-Register) and Change Notification Application March 27, 2023
Malaysia: MDA Issued Second Edition Guidance Document (MDA/GD/0061) Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device March 24, 2023
Malaysia: MDA Issued the First Edition Guidelines on “Notification of Custom-Made Medical Device” (MDA/GD/0064) March 13, 2023
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Malaysia: Draft guidance for requirements on certificate application of CFS, MC and CFS EO medical devices January 12, 2023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
