Detailed Guidance is now available online for manufacturers wishing to sell devices in the Kingdom of Saudi Arabia. This article explains where to find the information online.
Saudi Arabian market authorisation applications
Currently, a large percentage of Saudi Arabian market authorisation applications are being rejected at the initial review, which is delaying the process for many manufacturers and their Authorised Representatives.
The Saudi Authorities, the SFDA, have just published a document titled: ‘Guidance for Completing SFDA On-line MDMA Application Form – EU Jurisdiction’. This document is very useful to any manufacturer using European approvals or registrations (ie CE marking) as the route to obtain a Saudi Arabian market authorisation.
A more detailed article on the medical device regulations that apply to the Kingdom of Saudi Arabia, and the use of customs to restrict the import of medical devices without a valid Medical Device Market Authorisation, appears in Issue 4 of the SGS Medical Devices Newsletter.
The document is based on real experience in reviewing applications and if used can speed up the process for manufacturers.
This document is available here.