Malaysia: Exploring Registration Options: MDA’s Guidelines for IVD Analyzer Registration November 21, 2023
Malaysia: MDA’s Medical Device Advertisement Application Transitions to Paperless Starting December 2023 November 15, 2023
Malaysia: MDA Announces Harmonized QMS Standards for Medical Device Registration in 2024 November 15, 2023
Malaysia: Implementation of the use of Electronic Medical Device Registration Certificate in Malaysia November 8, 2023
Malaysia: The MDA To Cease The Issuance Of Certificate Of Free Sale (CFS) For Export Only Medical Device November 8, 2023
Malaysia: MDA Released Guidance Document MDA/GD/0065: Placement of HIV Self-Test (HIVST) Kit in the Malaysian Market September 6, 2023
Malaysia: MDA released Circular Letter No. 1 Year 2023: Permission for HIV Self-Test Kits Placement in the Malaysian Market September 6, 2023
Malaysia: Draft Regulation for Public Comments: Importation of Medical Device for Re-Export September 6, 2023
Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use August 14, 2023
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Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS June 28, 2023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
