Saudi SFDA Medical Device Classification 

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

1. What is the purpose of 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.

2. How are medical devices classified by the SFDA?

The SFDA classifies devices into four classes:

• Class I (Low Risk)
• Class II (Moderate Risk)
• Class III (High Risk)
• Class IV (Very High Risk)

3. What factors determine a device’s SFDA classification?

Key factors include the device’s intended use, risk to patients, duration of use, and whether it is invasive, active, or implantable.

4. Is SFDA classification mandatory for all medical devices?

Yes, any medical device entering the Saudi market must undergo SFDA classification to ensure compliance with national regulations.

5. How can manufacturers determine the classification of their devices?

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.