DRC is a licensed Authorized Representative (AR) in Saudi Arabia. In compliance with the Saudi Food and Drug Authority (SFDA) regulations, overseas medical device manufacturers are required to appoint a local AR to serve as the official liaison with the SFDA.

In addition to representing our clients, DRC provides expert regulatory consultation services to support manufacturers in obtaining SFDA approvals for their products.

We are not only a licensed Authorized Representative but also hold a Regulatory Consultation License, enabling us to deliver comprehensive, end-to-end support for medical device companies seeking to enter the Saudi market.

With a proven track record, DRC has successfully supported both local and international manufacturers in navigating SFDA regulations. Our services cover a wide range of Medical and In Vitro Diagnostic Devices (IVDs), including but not limited to:

Acting as a professional Authorized Representative registered with the SFDA

Facilitating Medical Device Marketing Authorization (MDMA) applications

Assisting with Medical Device Importation License (MDIL) processes

Managing reporting through the National Center for Medical Devices Reporting (NCMDR)

Providing guidance on the Product Classification System (PCS) to determine regulatory pathways

With our expertise, we ensure that your medical and IVD devices meet all SFDA requirements, streamlining your entry into the Saudi market.