A standard has been established to predict the class of digital medical devices at the development stage.
The Ministery of Food and Drug Safety said on the 20th that it revised the "Guideline on classification and class designation for digital medical devices." The key is the addition of class-by-class classification examples reflecting recent approval cases and a flowchart to help determine class.
Digital medical devices are divided into classes 1 to 4 depending on the patient's condition, the impact on diagnosis and treatment, and the level of risk if performance degrades.
The revision clarified the class criteria through real cases. Decision support for acute myocardial infarction and stroke in the emergency room is class 4; MRI- and CT-based brain tumor interpretation is class 3; screening for sleep apnea and suggesting insulin dosage are class 2; and improving medical image quality and the like are class 1.
A flowchart was also introduced to simplify the class determination process.
The Ministery of Food and Drug Safety said, "It will be possible to quickly predict the class from the early stages of development," and added, "We will continue to supplement the cases and criteria."