FAQ
FAQ
What are the requirements for the inspection of medical devices manufacturers?
Available on the link below :
Is it possible to import used medical devices?
importation of used medical devices is not allowed
What items (products) need to be provided with a temperature indicator/ data logger during transportation?
- 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.
What are the custom entry ports designated to medical device products?
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
Is the document (Declaration of conformity) for clearance the same as the document for registration?
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
Can I appeal to the rejection decision ?
The appeal process to rejected shipments is published at: (Click here)
What are the medical devices clearance conditions and requirements ?
How to update the responsible person information in the radiation emitting medical devices assessment report?
Contact the radiological health executive administration via this e-mail: rh.md@sfda.gov.sa
What are the requirements of evaluating the safe use of radiation emitting medical devices in healthcare facilities?
"You can find the requirements and guidance through this link
https://www.sfda.gov.sa/sites/default/files/2021-03/RequirementRadiationProtectionSafetyE.pdf