Post-Market Surveillance Overview
Post-market surveillance (PMS) obligations for medical device manufacturers and LARs under Malaysia's Medical Device Act 2012 (Act 737).
Adverse Event Reporting
Mandatory adverse event (vigilance) reporting requirements for medical devices in Malaysia, including reportable events, timelines, and MDA reporting process.
Field Safety Corrective Actions (FSCA)
Requirements for initiating, implementing, and notifying MDA of Field Safety Corrective Actions (FSCAs) and Field Safety Notices (FSNs) in Malaysia.
Mandatory Problem Reporting (MPR)
Malaysia-specific Mandatory Problem Reporting (MPR) requirements under Act 737, including who must report, reporting timelines, and the MyMDA reporting process.
Periodic Safety Update Reports (PSUR)
PSUR requirements for medical devices in Malaysia, including frequency, content, and submission to MDA under Act 737.
Change Notification & Significant Changes
Notifiable vs non-notifiable changes to registered medical devices in Malaysia, the change assessment process, and re-registration triggers under Act 737.