Authorized Representative Services
What Is an SFDA Authorized Representative (AR)?
An authorized representative is a local Saudi company that represents foreign manufacturers of medical devices and health products with the Saudi Food and Drug Administration. The SFDA requires the appointment of an authorized representative before products can be registered with it.
An authorized representative is not required to have commercial rights in the market, but is responsible for ensuring that products comply with the SFDA’s requirements.
Who Needs an Authorized Representative in Saudi Arabia?
Foreign companies and establishments need an authorized representative in Saudi Arabia with the SFDA to ensure compliance with the required conditions, especially with regard to the following products:
- Health products
- Medical devices
ICC is a Saudi authorized representative medical devices in Saudi Arabia, as well as medical supplies.
How does the Appointment Process Work?
The SFDA requires the signing of an approved representation agreement between the manufacturing companies and their approved Saudi representative, and its minimum validity is one year.
Why Appoint ICC as Your Saudi AR?
ICC represents factories and overseas establishments within the Kingdom of Saudi Arabia, monitors all services required to register the factory or products, submits complaints and withdraws products, and fully represents the manufacturers within the Kingdom of Saudi Arabia, including opening accounts and obtaining all licenses for cosmetics, food, and medical devices and supplies.
Frequently Asked Questions
Can a Manufacturer Change Its Authorized Representative?
Yes, the manufacturer can change the authorized representative, this does not require the approval of the previous representative, and there is no need to re-register the products after transferring the authorized representative.
Can One Manufacturer Appoint More than One AR?
Yes, the manufacturer can appoint more than one authorized representative in Saudi Arabia, but with different agreements.
Does the AR Support Product Recalls and Incident Reporting?
Yes, ICC is responsible for product recall support and reporting, and comprehensively represents foreign manufacturers in Saudi Arabia in cosmetics, food, medical devices, and supplies.
