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South Korea MSFD medical device classification 

South Korea regulates medical devices through the Ministry of Food and Drug Safety (MFDS). The MFDS, formerly known as the Korea Food and Drug Administration (KFDA), oversees the safety and efficacy of medical devices in the country. Similar to other regulatory authorities, the MFDS has implemented a classification system for medical devices to categorize them based on their intended use and level of risk. While specific details may have evolved since my last update, the classification system generally consists of several classes, each with its own regulatory requirements.

  • Class I: Very low-risk devices that are non-invasive and pose minimal risk to patients. Examples may include bandages, non-invasive thermometers, and certain types of surgical instruments. 
  • Class II: Low-risk devices that may be invasive or pose a moderate risk to patients. Examples may include certain types of diagnostic devices, powered wheelchairs, and some surgical gloves. 
  • Class III: Moderate-risk devices that are invasive or pose risk to patients. Examples may include implantable devices, certain types of surgical implants, and advanced diagnostic imaging equipment. 
  • Class IV: High-risk devices that are invasive or pose significant risk to patients. Examples may include implantable devices, certain types of surgical implants, and advanced diagnostic imaging equipment.