Medical Devices

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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Guidance on Content of Labeling of Contact Lenses and its Solutions (MDS-G14)

2024-10-01
Guidance on Content of Labeling of Contact Lenses and its Solutions (MDS-G14)
Guide
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Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)

2023-10-16
Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)
Requirement
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SFDA, HPRA Discuss Areas of Future Cooperation

2023-05-08

His Excellency the CEO of the Saudi Food and Drug Authority(SFDA), Dr. Hisham bin Saad Aljadhey, and his accompanying delegation met today, Monday, with the CEO of the Irish Health Products Regulatory Authority (HPRA), Dr. Lorraine Nolan.

This visit comes on the sidelines of SFDA official participation at the 4th meeting of the International Heads of Food Agencies Forum (IHFAF) taking place this year in Ireland.  

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SFDA Recommends to Test Blood Sugar at Home Two or Three Hours after Meals

2023-04-05

The Saudi Food and Drug Authority (SFDA) has recommended performing a home blood sugar test two to three hours after meals to ensure the device's safety and accurate readings. If blood sugar (glucose) levels increase during fasting, the SFDA recommends seeking medical attention from a specialist.
In addition, the authority recommended examining the glucose test strip's expiration date, buying devices that save previous measurements, washing and drying hands before a test, estimating how much blood was drawn, and inserting the test strip in the appropriate location.

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