Full-Spectrum Healthcare Market Services
From SFDA registration to hospital-level distribution, we provide every capability your company needs to enter, grow, and lead in Saudi Arabia.
Your Path to the Saudi Market
A structured, four-stage process that takes you from market assessment to sustainable commercial growth.
Market Assessment
We evaluate your product portfolio against Saudi market needs, competitive landscape, and SFDA pathway requirements.
Regulatory Filing
Full SFDA registration management — technical file preparation, submission, follow-up, and approval tracking.
Commercial Launch
Product launch strategy, pricing, key account targeting, and managed entry agreements with MOH and private hospital groups.
Growth & Scale
Ongoing distribution management, market expansion, tender support, and continuous regulatory compliance monitoring.
Medical Distribution
Our ISO-compliant distribution infrastructure covers every Saudi region with reliable, traceable, and temperature-controlled logistics. We hold established relationships with MOH, NUPCO, and major private hospital groups.
- Kingdom-wide delivery network across all 13 regions
- Cold-chain and ambient storage facilities in Riyadh
- NUPCO and MOH tender participation and fulfilment
- Serialisation and traceability compliance
- Consignment stock management for high-value lines
- Real-time inventory visibility and reporting
Business Development
Our commercial team operates at the highest levels of the Saudi healthcare market, opening doors that take years to build independently. We translate your product value into Saudi commercial success.
- C-suite hospital engagement and clinical stakeholder mapping
- KOL (Key Opinion Leader) development and clinical advocacy
- Product demonstrations and clinical evaluation programmes
- Formulary inclusion and preferred supplier positioning
- Government tender strategy and pricing advisory
- Commercial contract negotiation and renewal management
Market Access & Regulatory
Saudi Arabia's SFDA registration process is rigorous and time-consuming. Our dedicated regulatory team has a proven track record of successful registrations across all medical device and disposable categories.
- SFDA establishment and product registration (Class A–D)
- Technical documentation preparation and gap analysis
- Labelling and IFU Arabic translation and compliance
- Post-market surveillance and vigilance reporting
- Import licence management and customs clearance
- Annual registration renewal and lifecycle management
Healthcare Technology
Saudi Arabia's digital health agenda is creating new opportunities for innovative European technology companies. We provide market access, integration support, and commercial partnerships for digital health, AI diagnostics, and connected care solutions.
- Digital health market assessment and pathway mapping
- MOH and CCHI (Council of Cooperative Health Insurance) navigation
- Hospital IT integration and procurement support
- Pilot programme design and clinical evaluation
- Software as a Medical Device (SaMD) regulatory support
- Reimbursement pathway advisory
Strategic Partnerships
We structure exclusive and non-exclusive distribution agreements tailored to your commercial objectives, risk profile, and Vision 2030 localisation requirements. Our legal and commercial team ensures every partnership is structured for long-term success.
- Exclusive distributor agreement structuring and negotiation
- Joint venture and co-promotion frameworks
- In-country compliance and Vision 2030 localisation support
- Strategic alliances with key regulatory and industrial bodies