Requirements for Port of Entries 

- Requirements :

1-Temporary Requirements for Clearing Medical Devices and IVD Medical Devices​ 

 - Attestations:

 1 - Attestation to import IVD medical devices

2 - Attestation to import medical devices according to medical devices regulation


  • Registration and Licensing Requirements

    - Import Permission Requirements :

    1 - Import permit requirements for IVD medical devices

 

  •  Product Classification Requirements:

   1- Product Classification Requirements

  • Forms and Attestations:

    1-Application form to request initial approval for medical devices establishments  

    2-Application form to support technical staff of medical devices establishments

  •    Importation and Clearance Requirements for Radioactive Products:

      1- Temporary Importation and Clearance Requirements for Imaging/Radioactive Products

     2- Application for Imaging/Radioactive Products Importation and Clearance

     3 - Temporary Importation and Clearance Requirements for Particle Accelerators

  • Surveillance and Biometrics Requirements:

    - Requirements:

  1- FSNs Provisions and Follow-up procedure

  2- Provisions for Closing FSNs Affecting KSA

 - Forms and Attestations:

1-Statement Confirming KSA is Not Affected By FSN

2-Confirmation Statement for Completing the Corrective Actions Required in the FSN

  • Requirements for Storage and Transport of Medical Devices and Products

        1- Requirements for storage and transport of medical devices and products​​

  • SFDA Certification Requirements For Diagnostic , Nuclear Medicine and Radiotherapy Departements