Medical Devices

Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)

2023-09-28
Guidance on SFDA Requirements for Quality Assurance Programs for Radiation Emitting and Imaging Devices (MDS-G15)
Guide
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Question

What are the requirements for the inspection of medical devices manufacturers?


Answer

Available on the link below : https://www.sfda.gov.sa/en/regulations/87120


Question

Is it possible to import used medical devices?


Answer

importation of used medical devices is not allowed


Question

What items (products) need to be provided with a temperature indicator/ data logger during transportation?


Answer

Medical IVD's devices, Medical IVD and non-Medical IVD’s.  Chilled and frozen foods.  Any shipment requires a specific temperature for transportation and/or storage, according to the manufacturer's instructions, shall contain data logger (digital temperature indicator) activated from the time of shipping.


Question

What are the custom entry ports designated to medical device products?


Answer

1.       King Khaled airport - Riyadh 2.       Dry port - Riyadh 3.       King Abdulaziz airport - Jeddah 4.       Jeddah Islamic sea port - Jeddah 5.       King Abdullah Sea port - Rabigh 6.       King Fahad Airport - Dammam 7.       King Abdulaziz sea port - Dammam 8.       King Fahd Causeway – Al-Khobar 9.   Al-Batha outlet - Al-Ahsaa 10.   Al-Hadethah outlet – Qurayyat


Question

Is the document (Declaration of conformity) for clearance the same as the document for registration?


Answer

The clearance document differs from the “declaration of conformity of the shipment to the control regulation for medical devices and products” and a document that mentions the information of registration and licensing of the products in the shipment and the manufacturer’s acknowledgment that the products were shipped by the importer


Question

Can I appeal to the rejection decision ?


Answer

The appeal process to rejected shipments is published at:  (Click here)  


Question

What are the medical devices clearance conditions and requirements ?


Answer

  Medical Device clearance conditions and requirements are published at: (Click here)    


Checklist for Quality Manual Form

2023-08-06
Checklist for Quality Manual Form
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Requirements on Importation and Shipments Clearance of Medical Devices and Supplies (MDS-REQ5)

2023-05-21
Requirements on Importation and Shipments Clearance of Medical Devices and Supplies (MDS-REQ5)
Requirement
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