Saudi Arabia (KSA) Authorized Representative for Medical Device Manufacturers
Medical device manufacturers with no presence in the Kingdom of Saudi Arabia (KSA) are required to appoint a Saudi Arabia Authorized Representative to locally manage their registration effort. Your KSA Authorized Representative serves as a liaison between you and the Saudi Food & Drug Authority (SFDA), the country’s ministry of health.
Alshedwy Group can act as your Saudi Arabia Authorized Representative
Alshedwy Group is a native local Saudi MD regulatory affairs consultants, and can act as your KSA Authorized Representative. In this role we will act as your “regulatory liaison” with the SFDA and fully manage your registration effort. We are a fully independent Authorized Representative able to focus 100% on medical device and IVD regulatory issues, and your successful KSA registration is our goal.
What we provide as your KSA Authorized Representative
As your KSA Authorized Representative, our services include the following:
- Submitting your medical device or IVD registration to the SFDA
- Administering all registration fees
- Notifying the SFDA of any changes to your device
- Coordinating adverse event reporting to the SFDA with you and your distributors
- Supporting device recalls or Field Safety Corrective Actions (FSCA) if needed
- Assisting you in providing required marketing and advertising materials
- Making ourselves available at all times to liaise between you and the SFDA
We are a fully independent Authorized Representative able to focus 100% on medical device and IVD regulatory issues, and your successful registration in Saudi Arabia is our goal.
Please contact us at your convenience for a free consultation at: +966 502015100 or regulatory@alshedwygp.com