Our Services
MEDICAL DEVICES
Medical Device Regulatory Services
For Overseas Manufacturers
AR Appointment & Management: Act as your legal SFDA representative in KSA
MDMA Preparation & Submission: Full dossier compilation and GHAD submission
Technical File Review & Gap Analysis: Pre–submission compliance check
SFDA Query & Deficiency Management: Rapid, expert responses to SFDA queries
MDMA Renewal: Timely renewal before certificate expiry
MDMA Update & Variation: Post–approval changes and updates
Post–Market Surveillance (PMS): AE reporting, recalls, NCMDR submissions
UDI / Saudi–DI Registration: Unique Device Identifier database management
Saber Product Registration: Product conformity license for customs clearance
Product Classification: SFDA classification determination requests
For Local Saudi Companies
ISO 13485:2016 Documentation: QMS documentation for certification readiness
Medical Device Establishment License (MDEL): Full MDEL application support
SOPs for MDEL Compliance: Tailored Standard Operating Procedures
Medical Device Importation License (MDIL): Import authorization management
SFDA Warehouse Certificate: Compliant storage facility licensing
Product Registration Support: Registration under local company account
MDMA Renewal & Update: Lifecycle management of existing certificates
Regulatory Advisory & Compliance: Ongoing SFDA compliance guidance
MDMA Certificate Transfer: Transfer from other ARs to IRME account
Advertising Approval: Medical device advertising compliance