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Malaysia: MDA Withdrawn the Guidance Document: MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS June 28, 2023
Singapore: The HSA Recognized By WHO As Stringent Regulatory Authority (SRA) For High-Risk In Vitro Diagnostic Medical Devices (IVDs) June 27, 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
Singapore: Draft for Comments on GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3 May 10, 2023
Malaysia: MDA Announced Transition Period for the Implementation of Electronic Medical Device Registration Certificate May 10, 2023
Philippines: Operating Periods of The Philippines FDA Online Services during System Maintenance and Upgrade April 6, 2023
Philippines: Food and Drug Administration (FDA) issues Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices not included in the Registrable List of Medical Devices April 6, 2023
Singapore: HSA has been recognized as a comparable overseas regulator for medical devices by the TGA March 28, 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
Vietnam: Vietnam Government released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management March 21, 2023
Singapore: Fifth Revision of GN-21: Guidance On Change Notification For Registered Medical Devices March 13, 2023
