Annex-3 (MD) of SFDA Medical Device Registration Process|Saudi Food & Drug Authority L-6

Annex-3 (MD) of SFDA Medical Device Registration Process|Saudi Food & Drug Authority L-6‪@ivdmanufacturing7208‬

Why Saudi Arabia?
Saudi Arabia is the largest and most populous country in the Gulf Cooperation Council (GCC), with a population of over 37 million and a GDP of over $1.1 Trillion. The country has a high demand for healthcare services and products, driven by factors such as (Ahmed Ali Alasiri et al., 2022):

A growing and aging population
A rising awareness of health and wellness among the public
A government commitment to improving the quality and accessibility of healthcare
These factors have created a booming market for medical devices in Saudi Arabia, which is expected to grow from $2.0 billion in 2022 to $3.3 billion by 2032, with a compound annual growth rate of 5.9%.

But how can you get your device approved by the SFDA and start selling it in Saudi Arabia? Let’s find out.

Queries-
How to Register Your Device with the SFDA?
Appoint a Local Authorized Representative
Classify Your Medical
Required Document for SFDA Medical Device Registeration