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PCI Gases Achieves Saudi FDA Authorization For Medical Oxygen Systems
Expanding access to Reliable Medical Oxygen in the Middle East
PCI Gases is proud to announce that our Deployable Oxygen Concentration Systems (DOCS 80, 200, and 500) have officially received Medical Device Marketing Authorization (MDMA-2-2025-2984) from the Saudi Food and Drug Authority (SFDA).
This certification establishes PCI Gases as an authorized medical equipment provider in Saudi Arabia. More importantly, it unlocks access to healthcare projects across the Middle East, North Africa, and beyond, where SFDA approval is widely recognized.
Why the Saudi FDA Certification Matters
The SFDA Medical Device Marketing Authorization is a critical milestone for PCI Gases. Without this certification, oxygen generators cannot be categorized as medical devices in the region. With it, DOCS units are officially approved for medical use. As a result, new opportunities are now open, including:
Government and private tenders – Hospitals and ministries now require SFDA-certified systems to qualify for oxygen projects.
Private hospital adoption – Healthcare providers can confidently integrate DOCS oxygen generators into new facilities.
Regional recognition – Countries such as Turkey, Syria, and Libya increasingly request Saudi FDA approval as a benchmark.
Reconstruction efforts – The certificate will be required for committee approvals in rebuilding initiatives across Syria and Libya.
In short, the SFDA certificate is the key to medical oxygen projects in the MENA region.
Strengthening Healthcare Across MENA
Each country in the Middle East and North Africa may issue its own FDA authorization. However, Saudi FDA approval accelerates acceptance across the region. In many cases, it serves as the foundation for additional national certifications.
For PCI Gases, this milestone reinforces our commitment to delivering safe, sustainable, and self-sufficient medical oxygen solutions to hospitals and healthcare facilities across the region.
Why PCI Gases?
As a long-standing innovator in oxygen supply systems, PCI Gases designs solutions for challenging environments — from hospitals in rural Africa to emergency response units worldwide. Our DOCS units (Deployable Oxygen Concentration Systems) offer on-demand, energy-efficient oxygen at the point of care. Additionally, they minimize dependence on logistics and cylinder deliveries.
With Saudi FDA authorization secured, PCI Gases is ready to support the next generation of healthcare projects across Saudi Arabia, the Middle East, and North Africa.
📩 Contact us to learn more about our DOCS oxygen systems for hospitals and clinics!
🌐 Visit: https://www.pcigases.com/
VSA Technology
To produce oxygen from air, PCI uses a proprietary Vacuum Swing Adsorption (VSA) process that eliminates many of the design problems associated with traditional on-site gas separation systems (PSA). Our innovative VSA system eliminates the need for process valves, feed air compressors, associated dryers and feed air filtering systems. Our robust VSA oxygen process extracts maximum sieve and power efficiencies = low cost (both CapX and OpX) high purity oxygen generation. Oxygen produced is 93% purity. Additional product/systems features include load following, remote monitoring and diagnostics along with an industry only 10-year warranty on the adsorber bed vessel. Average life span of our systems is 10-15+ years.
About PCI Gases
PCI Gases, headquartered in Riverside, California, is a global leader in advanced on-site gas generation systems. Specializing in VSA technology for oxygen production, the company has been delivering innovative gas separation solutions since 1984. PCI Gases serves a wide range of industries, including medical, industrial, aquaculture, biogas, water treatment, and military applications.With a mission to empower industries by providing autonomy in oxygen and nitrogen supply, PCI Gases helps clients reduce costs and improve sustainability. Their vision is to decentralize gas supply, offering economical and environmentally responsible solutions worldwide. Through a commitment to innovation and operational efficiency, PCI Gases continues to reshape industries and enhance the total cost of ownership for their customers.
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