Authorized Representative Overview
What an Authorized Representative (AR / LAR) is, why one is mandatory for foreign manufacturers in Saudi Arabia, and what the AR role entails.
AR Obligations
Detailed obligations of an Authorized Representative (AR) in Saudi Arabia under MDS-REQ 9 — registration, post-market, labelling, and change management.
MDEL Overview
Medical Device Establishment License (MDEL) — types, who needs one, validity, and how to apply via GHAD.
Medical Device Importing License (MDIL)
The MDIL — when it applies instead of MDMA, which device categories are MDIL-eligible, and how to apply.
Changing Your AR
How to change your Authorized Representative in Saudi Arabia — the process, implications for the MDMA certificate, and labelling update obligations.
Storage & Distribution Requirements
SFDA requirements for medical device storage, warehousing, and distribution operations in Saudi Arabia — MDEL obligations, cold chain, and traceability.