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Medical Device Product Registration and Approval in Kingdom of Saudi Arabia

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​MEDICAL DEVICE REGULATION IN KSA

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Medical Device is regulated by the Saudi Food and Drug Authority (SFDA) in KSA whose objective is to protect and maintain public health within the KSA by the implementation of provisions ensuring a high level of safety and health protection of patients, users and third parties with regard to the use of medical devices as it relates to their manufacture, supply and use during their lifecycle. Medical devices are regulated under the Medical Device Interim Regulation.

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MEDICAL DEVICE REGISTRATION AND APPROVAL IN KSA

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The registration requirements carries elements from both Global Harmonization Task Force (GHTF). Devices shall comply with the relevant regulatory requirements applicable in one or more of the jurisdictions of Australia, Canada, Japan, the USA and the EU/EFTA, and additionally with provisions specific to the KSA to obtain registration approval.

Example of Approval

Source: SFDA

RESOURCES:

Regulations:

• https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementingRules.aspx

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Guidance Documents:

• https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/guidance.aspx