As a first step, overseas medical device manufacturers shall appoint a local Authorized Representative (AR) to obtain the AR license in order to proceed forward in the registration of medical device products in KSA.
SFDA has two approaches referring to the AR mandate for the manufacturers with/without subsites as follows:
- Agreement between a single legal manufacturer and an authorized representative.
- Agreement between an organization representing multiple legal manufacturers within a single company and an authorized representative.
As experts in the SFDA regulations, Bio-Standards has the capacity and desired knowledge to act as your Authorized Representative and ensure that the required information on the AR mandate will comply with the SFDA requirements.
As per the SFDA instructions, the AR mandate must be authenticated from the authorities mentioned below:
If the legal manufacturer is located outside KSA, the AR mandate shall be authenticated by all the following parties:
- Chamber of Commerce in a foreign country.
- The Ministry of Foreign Affairs in a foreign country.
- The Saudi embassy in a foreign country.
- The Saudi Foreign Ministry.
AR license can be attained within 1-2 weeks from the date of submission.
AR license renewal application can be initiated two months prior to the expiry date. AR license can only be applied using an authenticated AR mandate valid for the desired number of renewal years.
| FEE STRUCTURE PER CERTIFICATE/LICENSE | ANNUAL APPLICATION FEE |
| AR License Fee | SAR 2,600 annually |