今回のA製品のMF変更をPMDAに申請をし、申請内容に対し、PMDAからお問い合わせをいただいています。1番から5番まで、全部で5項目ありますが、1番の質問にある、"missing of corrected and added to JDMF"と"Actual change"については、変更の申請時に、申請理由の項目がありますが、その中の二つです。追って、申請理由のリストを送付します。
We have applied PMDA for the change of MF of the product A at this time.
Regarding the application, we have received an enquiry from PMDA.
There is 5 categories from section 1 to 5.
On the question 1 saying "missing of corrected and added to JDMF" and "Actual change" means two out of the sections of "reason of application" when submitting the change.
Therefore I will send a list of "reason of application" for you soon.
