This message was posted by a user wishing to remain anonymous
Hi ,
We have received the certificate , but with one change rejected , is there any way to reach the reviewer to ask for clarity or confirmation at this stage ?
Original Message:
Sent: 23-May-2023 21:10
From: Anonymous Member
Subject: China submission
This message was posted by a user wishing to remain anonymous
Hello forum members,
We are almost on the final stage of getting the change application approval from NMPA , however we received an update that they have rejected one of the changes but approved the rest. This seems to the final decision from the reviewer and the submission is passed on to the next stage for approval. We did try to provide supporting data for this rejected change but NMPA was not happy. We cannot have a device specific for China, is there anyway we can have the IFU updated to mention the particular feature ( whcih is not actually used by the users) is not approved for use in China , instead of getting hardware changes. Also is there any negotiation possibilities with the NMPA at hte final stage?