Achieving Saudi Arabia Medical Device Marketing Authorization (MDMA) with Precision and Efficiency
Project Summary
The project scope included consulting on medical device regulation of Saudi Arabia and authoring technical file documents for submission to the Kingdom of Saudi Arabia’s electronic system for Marketing Authorization. The medical devices in scope are monopolar devices used for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic procedures.
Challenges
Celegence Solution & Approach:
Celegence authored and/or compiled the documentation necessary to achieve marketing authorization in Saudi Arabia including:
Highlights:
Project Achievements
Celegence delivered the following value and business impact to the client:
Project Success
Celegence’s expertise enabled the client to secure Saudi MDMA approval swiftly for their Class C laparoscopic devices, overcoming regulatory complexities and ensuring full compliance with SFDA standards, underscoring Celegence’s commitment to regulatory excellence.