Scope change in Japan - Class I disposable medical devices

[smartinez]

Hello all, first time poster long time lurker.


I was wondering if anyone has had experience adding to their scope in Japan. We currently have approval for class I disposable devices in Japan and want to add repairs to our scope. I have been looking around the internet but have been coming up empty.

Let me know if anyone can point me in the right direction or point me to the right standard to read!


Thanks!!!