MDA-CAB WORKSHOP 2024 (SERIES II): ENHANCING COMPLIANCE AND EFFICIENCY IN MEDICAL DEVICE CERTIFICATION

The MDA-CAB Workshop 2024 (Series II), themed “Enhancing Compliance and Efficiency in Medical Device Certification,” was successfully held on October 24 and 25, 2024, at the prestigious Cyberview Resort & Spa, Cyberjaya. Drawing 200 participants from across Malaysia’s medical device sector, the workshop served as a collaborative platform for Conformity Assessment Bodies (CABs), industry leaders, associations, and regulators. Organized by the Pre-Market Controls Division’s CAB Registration Unit (CABRU), the event featured a comprehensive agenda that included expert presentations, interactive group discussions, and plenary sessions focused on advancing the quality and efficiency of medical device certification.

 

 

Participants engaged deeply in discussions centered around critical topics, such as the development of mutual report templates, refining turnaround times, and implementing robust checklists for various stages of medical device evaluation. Notable sessions included the APACMed Presentation on Predetermined Change Control Plans (PCCP) and in-depth group discussions on refining Good Distribution Practice for Medical Devices (GDPMD) and verification report templates. The MDA Chief Executive, Dr. Muralitharan Paramasua, set the stage with an opening address, encouraging collaboration and innovation to meet the evolving needs of the medical device landscape.

 

 

 

The workshop concluded with group presentations and a closing summary from MDA, highlighting key outcomes and collaborative actions to advance regulatory standards. The CABRU team received positive feedback from attendees who appreciated the well-organized agenda, effective time management, and quality of the content presented. With its emphasis on enhancing compliance and certification processes, the MDA-CAB Workshop 2024 (Series II) has set a new benchmark for collaboration within Malaysia’s medical device regulatory framework. MDA looks forward to hosting an even more impactful workshop next year, continuing its mission to ensure the safety and efficacy of medical devices in Malaysia.

Prepared by,

CAB Registration Unit (CABRU)

Pre-Market Controls Division (BKPP)

Medical Device Authority (MDA)

Ministry of Health (MoH)

Date: October 27, 2024