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Saudi Arabia

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Saudi Arabia
Product Registration

MEDICAL DEVICE REGULATION IN KSA


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.


MEDICAL DEVICE REGISTRATION AND APPROVAL IN KSA


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

Product Registration
Extra RA/QA Suppprt
Extra RA/QA Support

MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION

ARQon provide onsite/offsite monthly regulatory support for regional registration in Saudi Arabia.


Contact Us for more details.

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Drug Services
Drug Services

THERAPEUTIC AND COSMETIC APPROVAL

ARQon provides therapeutic and cosmetic approval for Drug, Cell Tissue, Traditional Medicine, Health Supplements and Cosmetic in Saudi Arabia.


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Health Safety
Health Safety

WIRELESS, RADIATION AND PACKAGING APPROVAL

ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Saudi Arabia.


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