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In Vitro Diagnostic (IVD) Medical Device Regulatory Services

Saudi Arabia (SFDA)

MedWisdomLifescience provides specialized regulatory affairs support for In Vitro Diagnostic (IVD) medical devices seeking market entry in Saudi Arabia. IVD products are subject to strict regulatory oversight due to their direct impact on clinical decision-making and patient safety. Our expertise ensures compliant, efficient, and well-planned registration under Saudi Food and Drug Authority (SFDA) requirements.

IVD Products We Support

Our regulatory expertise covers a comprehensive range of In Vitro Diagnostic (IVD) products:

IVD Medical Devices

Reagents and test kits
Clinical chemistry and immunoassay kits
Molecular diagnostics
Rapid diagnostic tests
Instruments and analyzers
Software associated with IVD devices

Each product is assessed for risk classification (A–D) and regulatory pathway prior to submission.

Key Challenges

Key Regulatory Challenges for IVD Devices

Our proactive regulatory planning minimizes these risks and reduces approval delays.

Risk-based Classification Complexity

Especially for Class C & D IVDs

Extensive Performance Evaluation and Clinical Evidence Requirements

Detailed IFU, Labeling, and Arabic Documentation

Software Validation and Cybersecurity Expectations

Alignment with GHTF/IMDRF Principles

Potential Requests for Additional Performance Data or Clarifications

SFDA Fees

SFDA Government Fees – IVD Medical Devices (Indicative)

SFDA fees vary based on device classification and application type:

Note: Fees are subject to SFDA updates and may vary depending on submission scope.

IVD Device Marketing Authorization

Approx. SAR 10,000 – 30,000 per device

Establishment Registration / License

Approx. SAR 5,000 – 10,000

Modifications / Variations

Additional fees apply based on change type

SFDA Timeline

Tentative SFDA Registration Timeline – IVD Devices

Higher-risk IVDs may require extended review timelines.

Preparation & Gap Analysis

⏱️ 1–2 months

SFDA Review & Queries

⏱️ 4–8 months

Marketing Authorization Issuance

⏱️ Upon approval

Why Choose Us

Why MedWisdom Lifescience for IVDs

What Sets Us Apart

· Strong expertise in IVD classification & performance data
· Experience handling high-risk diagnostic submissions
· Structured documentation and query management
· Transparent timelines and regulatory clarity