Malaysia: Futurise Lead RegTalk 2025 – AI Medical Devices in Malaysia: Balancing Innovation and Safety September 16, 2025
Malaysia: Infographic on Implementation Requirements on Quality Management System (QMS) and Traceability Form September 12, 2025
Malaysia: Implementation of the Malaysia–China Medical Device Regulatory Reliance Programme (Pilot Phase I) August 6, 2025
Malaysia and China Establish Medical Device Regulatory Reliance Programme To Reduce Approval Timelines July 29, 2025
Malaysia: MDA Releases Third Edition of ASEAN Harmonised Medical Device Classification Guidance (MDA/GD/0062) June 20, 2025
Malaysia: MDA Releases Third Edition of Harmonised Borderline Products in ASEAN Guidance (MDA/GD/0063) June 20, 2025
Malaysia: MDA Introduces Enhanced Dispute Resolution Process for Medical Device Classification June 19, 2025
Malaysia: MDA Announcement Re: Updated Approach for New Registrations with Expired EC Certificates June 17, 2025
Malaysia: MDA Announcement Re: Medical Device Re-Registration Must Be Submitted One Year Before Expiry via MeDC@St 2.0+ June 17, 2025
Malaysia: Implementation of Conformity Assessment Procedures for Medical Devices Approved by Recognized Countries May 15, 2025
Malaysia: MDA Seeks Public Comment on Draft Guidelines for Importing or Supplying Unregistered Medical Devices Through Special Access Exemptions Application May 6, 2025
