About the Measurement Function in the Medical Device Software, What Issues Should be Concerned About in the Registration Application Data?

The Guidelines for Medical Device Software Registration Review (2022 Revision) clearly States that the measurement function (also known as quantification and quantitative function) can be divided into graphic measurement function and objective physical measurement function. The former indirectly reflects the measurement results of objective things based on graphics, while the latter directly reflects the measurement results of objective things.

No matter what kind of measurement function, it is necessary to combine the factors such as measurement error and uncertainty to define the measurement accuracy index, such as linearity, accuracy, repeatability, reproducibility, range limit, display error, etc.

Registration applicants are required to provide research data on measurement accuracy and inform users in the instructions. In addition, for objective physical measurement, the accuracy indicators should be specified in the product technical requirements; and for graphic measurement, warning information about the accuracy of measurement should be provided in the instructions.