Hello, I cannot find the right Japan regulations or guidance on how to determine if a file conversion tool is a medical device, excluded, or is not considered a device.
The file conversion tool would do nothing other than change a file from one format to another (for example, it would be like converting from Google Sheets to Excel). There is no interface, no calculation, no control, just pure file conversion.
The file conversion tool would do nothing other than change a file from one format to another (for example, it would be like converting from Google Sheets to Excel). There is no interface, no calculation, no control, just pure file conversion.
