Stand Alone Software definition according to PMDA

K

kingkobra

#1
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?
 
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sreenu927

Quite Involved in Discussions
#3
Hi kingkobra,

If you got the reply from PMDA that stand alone software is not regulated, then you can sell it without any registration approval.

If you didn;t find the definition of the "stand alone software" under Japanese regulations, then you cna look into GHTF definition of "stand alone software", as Japan is one of the members of GHTF (now called as IMDRF).

But, at front end, what is the information that you had provided to PMDA when seeking the clarification.

Regards,
Sreenu
 
R

ryno fan

#4
Stand Alone Software definition from FDA?

Hello,

Is anyone aware of a definition provided by FDA for standalone medical device software or standalone software? Or even a definition in U.S. Code?

The context in which I ask is for the Unique Device Identifier rule FDA recently published. Specifically, I am trying to find out if interfaces software that is individually distributed, can be used with various laboratory information systems, and processes medical data would be considered "standalone software" by the FDA... Please note that this interface software is basically middleware that does not have a user interface like the LIS with which it would work.

Thanks
 
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