Malaysia Issues Second Edition of CAB Guidance for Conformity Assessment by Way of Verification

"The Medical Device Authority (MDA) released the second edition of its guidance document MDA/GD/0068: Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification in September 2025. The updated guidance provides detailed requirements for CABs to perform conformity assessment of Class B, C, and D medical devices, through verification of evidence from recognized regulatory authorities or notified bodies, in line with Section 7 of the Medical Device Act 2012 (Act 737). The revised edition streamlines procedures for both initial certification (new registrations) and recertification (re-registrations), while exempting Class A devices as set out in the Medical Device (Exemption) Order 2024. Key updates include removal of certain prior marketing requirements, expanded recognition of Singapore and Thailand regulatory authorities, clarification of review criteria for quality management systems and clinical performance, and refined reporting templates for both initial and recertification assessments. The guidance aligns with MDA’s policy of leveraging approvals from recognized jurisdictions to reduce duplication, lower costs, and expedite device registration in Malaysia, while ensuring compliance with the Essential Principles of Safety and Performance (EPSP)."