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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.  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:  

Medical Devices 

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 C - IVDs used for detecting an infectious agent that does not have a high risk of propogation. 
  • Class B - IVDs for self-testing with lower risk to patients. 
  • 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.