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We have made a medical application and want to put in the market of Japan,
We contacted PMDA through mail and in their response they have clearly said that PMDA does not regulate standalone software.
But on PMDA website, we could not find their definition of ?standalone software?. So we do not know whether our application is regulated or not. So can anybody help me to find the definition for "Stand alone Software " as per PMDA?
We contacted PMDA through mail and in their response they have clearly said that PMDA does not regulate standalone software.
But on PMDA website, we could not find their definition of ?standalone software?. So we do not know whether our application is regulated or not. So can anybody help me to find the definition for "Stand alone Software " as per PMDA?