Japan registration need manual without temperature reading

Jasmin

Registered
We have a product and for registering it in Japan the RA from Japan team is saying that the authorities there will not accept the registration because we have mentioned Temperature limit (-5 --- +50C & -30 --- +70C) in our manual. According to the authorities the temperature values will be in the manual only if they are other than the ambient temperature value.

From design control point of view, we have 1 Master copy (English language manual) and validation is done on that Manual. Then it is translated to other languages, Japanese being one of them. We cannot have old Master copy (English language manual) having some Temperature values and Japanese Language manual having no temperature values.

Now if the Japanese authorities are saying that they don’t want to have the Temperature range mentioned in the manual, my understanding is that we need to have a new Product SKU code for Japan with new Master copy without temperature values and translated Japanese manual without temperature values.

Is there any other way to solve this issue?
 
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