Medical Device Market Size
Market Value: Valued at approximately USD 2.5 billion in 2024, making it the largest medical device market in the GCC.
Growth Projections: Expected to grow to USD 3.3 billion by 2029, driven by Vision 2030 reforms.
Future Growth Potential
- Vision 2030 Healthcare Goals: Driving increased procurement and localization of medical devices.
- Hospital Expansion: Government and private investments are adding new hospitals and upgrading diagnostic capacity.
- Digital Health Focus: Rising demand for connected devices and AI-based technologies.
Registration Process
Regulatory Authority: Saudi Food and Drug Authority (SFDA) — Medical Devices Sector.
Device Classification:
- Class I — Low Risk
- Class IIa/IIb — Moderate Risk
- Class III — High Risk
Registration Requirements:
- All devices must be listed in the GHAD system.
- Approval may be streamlined if devices have prior GHTF market authorization (US, EU, Canada, Australia, Japan).
Local Representation: Foreign manufacturers must appoint a Legal Representative or Local Authorized Representative in KSA.
Quality Management: ISO 13 485 mandatory; manufacturing site audits may be requested.
Online Portal: GHAD system — https://mdma.sfda.gov.sa
Language Requirements: Arabic labeling is required; IFU can be bilingual.
Post-Market Surveillance: Includes vigilance reporting, mandatory adverse event reports, and field safety corrective actions.