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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.
Extra RA/QA Support
MONTHLY REGULATORY SUPPORT FOR REGIONAL REGISTRATION
ARQon provide onsite/offsite monthly regulatory support for regional registration in Saudi Arabia.
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.
Health Safety
WIRELESS, RADIATION AND PACKAGING APPROVAL
ARQon provides Wireless, Radiation, Packaging and Non-medical Device Approval in Saudi Arabia.
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