Post-Market Overview
Overview of post-market obligations for medical device manufacturers and ARs in Saudi Arabia — surveillance, vigilance, FSCAs, labelling, and MDMA renewal.
Adverse Event Reporting — NCMDR
Reporting serious incidents and adverse events to the SFDA via the National Centre for Medical Device Reporting (NCMDR) — obligations, timeframes, and process.
FSCAs & Recalls
Field Safety Corrective Actions (FSCAs) in Saudi Arabia — when they are required, Field Safety Notices, the recall process, and SFDA coordination.
PMS & PSUR Requirements
Post-market surveillance obligations by device class in Saudi Arabia — PMS Reports for Class A and Periodic Safety Update Reports (PSURs) for Class B, C, and D.
MDMA Renewal & Change Notification
How to renew an MDMA certificate in Saudi Arabia and how to notify the SFDA of significant device changes.
Labelling & Advertising
SFDA post-market labelling requirements, Arabic labelling obligations for home-use devices, and advertising pre-approval under MDS-REQ 8.