SFDA Medical Device Registration An Overview

KSA (Kingdom of Saudi Arabia) has been rated in the top 20 economically competitive countries in the world. SFDA is a regulatory authority for medical devices and IVDs sold and distributed in Saudi Arabia. MDMA approval is needed to place your devices in the Saudi Arabia market. SFDA reviews MDMA applications to prepare your submission carefully. Saudi Arabia updated their medical device regulations between 2019 to 2022, which affected device classification and changed the concept and content of MDMA (high-risk application). Due to the changes and updated guidance previously approved devices, IVDs, and medical supplies must comply with new regulations. As medical device regulatory consultants, we always keep an eye on changes in regulations and current updates so that we can serve better to our clients.