SFDA — Saudi Food & Drug Authority
Saudi Arabia's national authority for medical-device regulation. Gene Matrix manages its IVD submissions in line with the SFDA pathway.
Regulatory & Quality
Built on a regulated quality system.
Gene Matrix operates an integrated quality and regulatory system aligned with the standards required of a serious in-vitro diagnostics manufacturer — domestically and internationally.
ISO 9001 — Quality Management Systems
The international standard for quality management systems — providing the organisational backbone for consistent processes, continual improvement and customer focus across Gene Matrix operations.
ISO 13485 — Quality Management Systems for Medical Devices
The international quality-management standard for medical-device design, development and manufacture. Our quality system is built and operated to ISO 13485 requirements.
WHO Good Manufacturing Practice
Manufacturing operations are aligned with WHO GMP principles — ensuring product consistency, traceability, and contamination control.
CE-IVDR Alignment
Assay design, validation, and post-market surveillance are aligned with the EU In-Vitro Diagnostic Regulation (IVDR), supporting future European market access.
Cleanroom Classification
Manufacturing takes place in an ISO 5 (Grade A) critical zone within an ISO 7 (Grade C) background — designed for sterile-grade IVD production.
Quality, Traceability & Release Testing
Every lot moves through documented in-process controls, release testing, and a stability programme — with full lot traceability from raw material to finished product.
Regulatory Roadmap
From Saudi-first to globally recognised
A staged regulatory pathway — starting with SFDA, expanding through CE-IVDR, with WHO prequalification as a long-term ambition.
- 01
Operational Quality System
ISO 13485-aligned QMS, validated cleanroom, documented release testing and stability programme — operational today.
Current status
- 02
SFDA Submissions
IVD product submissions managed in line with the Saudi medical-device regulatory pathway, on a per-product basis.
Current status
- 03
CE-IVDR Pathway
Design, validation and post-market surveillance prepared in alignment with the EU IVDR — supporting future European market access.
Next milestone
- 04
WHO Prequalification (PQ)
A long-term ambition for selected public-health assays — opening procurement pathways with global health agencies.
Long-term
A note on registration status
Regulatory registration status varies by market and by individual assay, and progresses on a per-product basis. Gene Matrix is happy to share current status, validation data, and regulatory documentation with hospitals, distribution partners, and reference laboratories on request.