South Korea Ultrasound Software Requirements

S

shasti212

#1
Hi all,

My company manufactures ultrasound devices with software. In updating our licenses, they (doistributors and license holders) are asking for algorithms (something not required before but is now due to new regulations), however we are not comfortable providing this type of information. They asked for a "flow chart and brief explanation of algorithms", which leads me to think they don't understand what an algorithm truly is.

Does anyone else have experience with what they are asking for? It's just been a run around and I am not sure exactly what it says about software in the regulations.

Thanks!!
 
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sreenu927

Quite Involved in Discussions
#2
I had experience submitting registration dossiers to MFDS (previously, KFDA).
They need Software and Firmware algorithm flowchart with brief explanation, as part of the submission dossier. Initially, we had faced difficult times with our SW/FW colleagues and the local RA(Korea) - to understand what is required and unto what extent. Finally, we gave a basic flowchart of the algorithm and architecture diagram with explanation of each process or block and it was accepted.

Hope this helps!

Regards,
Sreenu
 
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