Saudi SFDA Medical Device Classification
The SFDA’s classification system generally follows international standards, such as those outlined by the Global Harmonization Task Force (GHTF), now succeeded by the International Medical Device Regulators Forum (IMDRF), and may also be influenced by the classification systems of other regulatory authorities.
The SFDA classifies medical devices based on factors such as the intended use, duration of contact with the body, level of invasiveness, and potential risks associated with the device. This risk-based approach helps ensure that medical devices entering the Saudi market meet strict safety, performance, and quality standards. By aligning its framework with global regulatory models, the SFDA supports smoother market access for manufacturers seeking approval in multiple regions.
Devices are typically placed into risk-based categories ranging from low-risk to high risk similar to Classes I, II, III, and IV used internationally. Understanding these categories helps manufacturers prepare accurate submissions and achieve faster, more efficient SFDA approval.
While specific details of the SFDA’s classification criteria may not be readily available, it typically includes classes similar to those found in other regulatory frameworks, such as:
Saudi
SFDA Medical Device Classification
Saudi Arabia classifies medical devices into four classes and uses the same 22 classification rules found in the MDR:
- Class A - Low risk (MDR Class I).
- Class B - Low to medium risk (MDR class IIa).
- Class A – Sterile or Measuring function - Low to medium risk (MDR Class I – sterile/measuring)
- Class C - Medium to high risk (MDR class IIb).
- Class A – Reusable surgical instruments - Low to medium risk (MDR Class I - reusable)
- Class D - High risk (MDR class III).
In Vitro Diagnostic Devices
IVD classifications are similar to those defined in the EU IVDR:
- Class A - Lowest risk. Examples include specimen receptacles and buffer solutions.
- Class B - IVDs for self-testing with lower risk to patients.
- Class C - IVDs used for detecting an infectious agent that does not have a high risk of propogation.
- Class D - IVDs that detect or are exposed to life-threatening transmissible agents or or transmissible agents and infectious diseases with a high risk of propagation.
Frequently Asked Questions: Saudi SFDA Medical Device Classification
SFDA classification ensures medical devices are assessed based on their risk levels, usage, and complexity. This helps regulate their safety and effectiveness in the Saudi market.
The SFDA classifies devices into four classes:
- Class I (Low Risk)
- Class II (Moderate Risk)
- Class III (High Risk)
- Class IV (Very High Risk)
Key factors include the device’s intended use, risk to patients, duration of use, and whether it is invasive, active, or implantable.
Yes, any medical device entering the Saudi market must undergo SFDA classification to ensure compliance with national regulations.
Manufacturers can refer to SFDA guidelines for device classification. Consulting with a
Saudi-authorized representative
or a
medical device consultant
can also simplify the process.
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