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GHAD Portal & MDS-REQ 1
MDMA Application & Technical File Strategy
MDMA Must Be Built Around a Defensible Technical File. The Medical Devices Marketing Authorization is the principal SFDA market-authorization route for medical devices intended to be supplied in Saudi Arabia. The application is supported by a technical file demonstrating conformity with SFDA requirements and the essential principles of safety and performance.
When This Support Is Needed
Preparing an initial MDMA application for Class A, B, C, or D medical devices or IVDs in Saudi Arabia
Restructuring an existing MDMA authorization following device line expansions or model additions
Transitioning legacy registrations to current unified GHAD electronic portal standards
Addressing SFDA requests for additional technical, clinical, or quality system information
What We Challenge Before Submission
Does the device family grouping strictly satisfy SFDA's 'kind of device' criteria?
Is every claim in the Arabic/English IFU supported by verifiable verification and validation data?
Are Free Sale Certificates (FSC) and QMS certificates current and properly authenticated?
Does the technical file provide adequate traceability from Essential Principles to test reports?
Are all manufacturing and sterilization sites correctly listed and aligned with AR authorizations?
Our MDMA Support Scope
MDMA route assessment and pre-submission application readiness
Technical-file compilation and assessment strategy under MDS-REQ 1
Device family and grouping assessment for consolidated submissions
Manufacturer and Saudi Authorized Representative (AR) data alignment
Declaration of Conformity and quality system (ISO 13485) evidence review
SFDA Essential Principles of Safety and Performance evidence mapping
Risk-management documentation and ISO 14971 benefit-risk review
Clinical evaluation reports (CER) and IVD performance evidence review
Labeling, packaging artwork, and bilingual Arabic/English IFU alignment
Electronic application submission and real-time tracking in the GHAD portal
Response drafting and technical rebuttal for SFDA queries and deficiency notices
Authorization-record review and post-approval documentation handover
Regulatory Rigor:
We do not begin with the submission portal. We begin with the regulatory basis that makes the MDMA application defensible.
Secure Your SFDA Medical Device Marketing Authorization (MDMA)
Our regulatory experts structure compliant technical files under MDS-REQ 1, submit through GHAD, and manage approvals.