We provide a variety of services to international companies will to come into the Kingdom of Saudi Arabia (KSA) starting with In-Country representation, to marketing and selling unique innovative products.
Medical device manufacturers who do not have any presence in the KSA are required to appoint an Authorized Representative (AR) to locally manage their registration processes. We as the Authorized Representative serve as a liaison between you and the Saudi Food & Drug Authority (SFDA), the country’s regulatory body for medical devices.
As your Authorized Representative we provide the following services:
1.Submitting your medical device or IVD registration to the SFDA
2. Administering all registration fee
3. Notifying the SFDA of any changes to your device
4. Coordinating adverse events reporting to the SFDA with you and your distributor
5. Supporting device recalls
6. Assisting in providing required marketing and advertising materials
For further information on how we can assist your company in entering into the Saudi Arabian market and becoming your strategic partner please contact us