Advancing Medical Device Conformity Assessments: MDA-CAB Workshop 2023 Recap
December 6 to December 7, 2023 - In a collaborative effort spearheaded by the Medical Device Authority (MDA), the MDA-CAB Workshop 2023, organized by the Pre-Market Controls Division (BKPP) in tandem with the Policy and Strategic Planning Division (DASAR), convened 89 auditors and technical personnel of all registered CABs under the Act 737. Held at the Meranti Hall, Level 6, MDA Office, Cyberjaya, the two-day event from December 6 to December 7, 2023, aimed to fortify standards and streamline processes within medical device certification.
The workshop's core purposes centered on establishing a standardized framework for conformity assessments, enhancing operational efficiency, fostering universal understanding of high-quality documents, and facilitating smoother registrations of medical devices. The agenda, structured to meet these purposes, featured interactive sessions, group discussions, and insightful presentations. Participants actively engaged in addressing challenges such as inconsistent assessment criteria, turnaround times, and issues related to technical documentation.
Facilitated by the certification experts of the CABs, the workshop incorporated real-world examples and practical materials, enabling collaborators to delve into the intricacies of their challenges. The second day concluded with group presentations and deliberations by the MDA, marking a collective commitment to continual improvement in medical device certification processes. The insights gained from this collaborative effort are poised to shape the future landscape of the medical device sector, ensuring heightened standards and efficacy in medical device certification.