Medical Device AR Licensing
Need to Register your Medical Device in Saudi Arabia?
As an overseas manufacturer, the first crucial step is appointing a local Authorized Representative (AR) with an AR license. This ensures compliance with Saudi FDA regulations.
We Simplify Your AR Selection:
REG SOLUTIONS, your Saudi FDA regulations experts, can be your trusted AR. We handle both types of AR mandates:
- Single-Site AR agreement: AR Agreement between the manufacturer and REG SOLUTIONS, this agreement to be used if the products that will be registered are manufactured in one site.
- Multiple-Site AR agreement: AR Agreement between the manufacturer and Reg Solutions, this agreement to be used if the products that will be registered are manufactured in more than one site, all the sites should be listed in the AR agreement.
Saudi FDA Authentication Made Easy
If the legal manufacturer is located outside the Kingdom of Saudi Arabia, the agreement shall be authenticated as the following:
The country member of (Hague Convention):
“Apostille” that been issued by an accredited body in the foreign country.
The country not member of (Hague Convention):
A) Chamber of Commerce in foreign country.
B) The Ministry of Foreign Affairs in foreign country.
C) The Saudi embassy in the foreign country.
D) The Saudi Foreign Ministry.
If the legal manufacturer is located within the Kingdom of Saudi Arabia, the agreement shall be authenticated by all of the following parties:
A) Chambers of Commerce and Industry.
B) The Embassy of the foreign party in the Kingdom.
C) The Saudi Foreign Ministry.
Focus on Your Business, We Handle the Rest
Let REG SOLUTIONS navigate the complexities of Saudi FDA registration. We'll be your one-stop place for AR selection, authentication, and ensuring a smooth, compliant registration process.
Guaranteed Compliance with Saudi FDA Requirements
Our in-depth knowledge ensures your AR mandate fulfills all Saudi FDA requirements. We also handle the authentication process, saving you time and hassle.