Saudi MD Authorized Representation Services
Your Saudi MD/IVD Authorized Representative
Hatem I. Alshedwy Comm. Est., a Alshedwy Group company, provides Saudi MD/IVD Authorized Representative (Saudi Auth. Rep.) services to Non-Saudi medical device manufacturers wanting to sell their products within the Saudi Arabia market.
Why is a Saudi Authorized Representative (Saudi Auth. Rep.) necessary?
If a manufacturer is based outside the Kingdom of Saudi Arabia, the Saudi Competent (regulatory) Authority (Saudi FDA) needs to be able to contact an entity or person, who is based within Saudi Arabia, and who acts on behalf of the manufacturer.
Non-Saudi manufacturers cannot simply have a post office box located in the Saudi Arabia (KSA); you are obliged to have a representative that is a registered business with a legitimate Saudi address.
There are certain policies and regulations associated with selling medical devices in the KSA, and these are continually being updated and changed. Your Saudi Auth. Rep. is aware of policy adjustments and regulatory changes that may occur and that may impact your business.
Your Saudi Authorized Representative has the responsibility of ensuring the manufacturer’s compliance with specific elements of the conformity assessment procedure set out in the SFDA-MDIR (medical device interim regulation) plus many of medical device sector implementing rules (MDS-IRs), also the national requirements of MD handling that applies to your specific product(s).
These include: contacts with Saudi authority SFDA, Notifications, Recall and Vigilance support. Alshedwy Group Services has extensive experience in these areas and can provide whatever level of assistance you need to make sure your company remains in compliance with the Saudi regulations.
Please contact us at your convenience for a free consultation at: +966 502015100 or regulatory@alshedwygp.com