SEMINAR BY THE MEDICAL DEVICE AUTHORITY ON REGULATORY UPDATES AT KENYIR BALLROOM, DOUBLETREE BY HILTON, PUTRAJAYA

12 October 2022 – Medical Device Authority (MDA) has organized Seminar by The Medical Device Authority on Regulatory Updates at Kenyir Ballroom, Doubletree by Hilton, Putrajaya. This seminar provides a platform for medical device establishments, medical device industry representatives, conformity assessment bodies, and stakeholders to discuss and share knowledge on medical devices’ key regulatory updates, as well as inspire networking between the industry players with the same interest in the medical device.

The objectives of this seminar is to provide updates on medical device regulations acts, and guidelines in Malaysia, sharing information on regulatory requirements for medical device re-registration in compliance with Act 737, to disseminate information on the latest development on ASEAN Medical Device Committee (AMDC) and Global Harmonization Working Parties (GHWP) and to assist and ease the industry to raise any issues relating to the medical device by making Mandatory Problem Reporting (MPR), Field Corrective Action (FCA), and Recall using the new Medical Device Centralized Reporting System (MeDCReSt).

This seminar has provided information on the regulatory updates, the re-registration process of medical devices and also introduce the newly launched system by MDA's Post-Market and Enforcement Division, Medical Device Centralized Reporting System (MeDCReSt), to facilitate the reports from the industry and the public.