Saudi Arabia’s healthcare sector is undergoing one of the most comprehensive regulatory overhauls in the region, driven by Vision 2030 and the Health Sector Transformation Program. The government is actively working to improve access, enhance quality, and introduce innovative delivery models that align with global health standards. These changes are supported by a growing legislative and regulatory framework that is reshaping the medical landscape and attracting international partnerships and private investment.
Core Regulatory Bodies and Legal Framework
At the centre of the regulatory ecosystem is the Ministry of Health (MoH), which leads national healthcare policy, oversees public hospitals, and supervises the licensing of the private sector. It works in coordination with:
- Saudi Food and Drug Authority (SFDA) – Regulates drugs, medical devices, and biotechnology
- Saudi Commission for Health Specialties (SCFHS) – Governs professional licensing and medical education
- Council of Health Insurance (CHI) – Regulates mandatory health insurance and benefit compliance
- Health Sector Transformation Program (HSTP) – Guides institutional reforms and integration
The MoH is also the lead agency for implementing SEHA Virtual Hospital and NABIDH, the Kingdom’s national electronic health record platform.
Health Law and the Role of the State
The Health Law, which serves as the foundational statute for healthcare delivery, mandates the government’s responsibility to provide preventive, curative, and rehabilitative services to all Saudi citizens. The law ensures:
- Patient rights, including access to information, confidentiality, and informed consent
- Legal pathways for public-private partnerships (PPPs) in healthcare
- Licensing and inspection of healthcare facilities under unified quality and safety benchmarks
The Health Law has recently been revised to embed patient-centric models further and accelerate private sector participation through more precise regulatory mechanisms.
Private Health Institutions Law and Digitisation Mandates
The Private Health Institutions Law governs the licensing and operations of private clinics and hospitals. Recent regulatory updates in 2024 and early 2025 include:
- Mandatory adoption of Electronic Medical Records (EMR) and interoperability with NABIDH
- Stricter penalties for facilities operating without updated digital health infrastructure
- Expanded scope for speciality and day-surgery centers to encourage diversification of private services
This digitisation drive is aligned with the MoH’s goal to integrate the public and private health systems by 2030 fully.
Workforce Licensing and Professional Accountability
The SCFHS remains responsible for licensing healthcare professionals, overseeing postgraduate medical training, and enforcing ethics and continuing professional development (CPD) requirements. Notable updates include:
- National revalidation framework introduced in 2024, requiring periodic competency reviews
- Centralised digital practitioner registry integrated with NABIDH and MoH licensing systems
- Expanded specialisation categories, including for telehealth and digital health roles
The SCFHS also plays a role in investigating malpractice and ensuring transparency in professional standards.
Drug and Device Regulation by SFDA
The SFDA governs pharmaceutical products, biologics, and medical devices. In 2023–2025, it launched several reforms to streamline innovation:
- Accelerated pathways for orphan drugs and personalised therapies
- Updated guidelines for clinical trials and digital therapeutics
- Enhanced post-market surveillance and adverse event reporting systems
These measures aim to attract life sciences investment and improve access to next-generation treatments.
Telehealth and Virtual Care Regulations
Saudi Arabia’s Telehealth Regulation, updated in late 2023, has become a model in the region. It permits:
- Remote diagnosis, treatment, and consultation via licensed platforms
- Cross-border telemedicine services for certain specialities
- Strict standards for patient data protection, platform licensure, and digital consent
The SEHA Virtual Hospital, now operational across all regions, connects primary care facilities to centralised speciality hubs, providing virtual access to over 30 specialities.
Health Insurance Regulation and Mixed Financing Models
The Council of Health Insurance (CHI) enforces regulations around employer-mandated health insurance for private sector and expatriate workers. In 2024–2025, CHI implemented:
- Expansion of the Unified Benefits Package (UBP) to cover chronic disease management and mental health
- Mandatory digital claims processing standards for insurers
- Pilot testing of integrated financing models involving private insurers and public hospitals
These reforms aim to shift the healthcare system toward value-based care, reduce public expenditure, and expand coverage across non-citizen populations and dependents.
Saudi Arabia’s healthcare laws are evolving rapidly to support a high-performing, patient-focused, and technology-driven medical ecosystem. The alignment of regulatory institutions, legal frameworks, and digital innovation is positioning the Kingdom as a regional leader in transforming the health sector. For healthcare investors, operators, and professionals, staying aligned with these regulatory developments is essential to unlocking opportunities in one of the most ambitious and reform-driven healthcare markets globally.