Sampling QC Requirements for Medical Electrical Device Export to Japan

P

pietpara

Hi everyone,

I have a question regarding final inspection quality control with sampling schemes (ISO2859) on a medical electrical device and how to deal with it when exporting to Japan.
Maybe someone has experience with this and can clarify for me.

Obviously, if one performs sampling, not all units in a batch are tested. So, also not all QC parameters are measured for each individual unit. However, I am told that for import of a medical device into Japan, authorities want to see the QC parameters for each imported unit (on a final inspection report delivered with the units).
If this is true, then how can one deal with that whilst still sampling?

I can think of only the following:
1) For Japan only 100% sampling is possible. i.e. Only the units from production that were sampled can be imported into Japan.
2) The inspection reports sent with the devices report only something like the statistical average of the samples from the lot.

Does anyone have experience in this and how to deal with it in a regulatory correct way?

thanks!

PietPara
 
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