Dear Anon
I would echo Grace's insights here - the time to discuss and settle concerns with the regulator is during the 3 review meetings and informal communications during the supplementary review phase. There is only 1 formal response to the supplementary notice - which must be made within 1 year from issue of the notice - and if the NMPA has now formally rejected your formal supplementary response it will be very difficult to now change their views.
One possibility, although it will be very fact-dependent, is to seek to make a further IFU change after you have received the approval change certificate. Possibly this could be documentary change only (ie no need to do further testing) but it is very hard to say without looking at the detail. I can ask our experts in Beijing to review if of interest.
Regards
Hamish King
CEO, Cisema
hamish.king@cisema.com
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Hamish King
hamish.king@cisema.comwww.cisema.com------------------------------
Original Message:
Sent: 30-May-2023 11:13
From: Grace Fu Palma
Subject: China submission
Looks like you are at the end stage of your China change application final stage. I assume that you have used your three times official consultation with your China NMPA technical reviewers already. You have also exhausted your final deficiency phase review. If all 4 chances are being used already for your supplementary (deficiency) phase review, you do not have any more official channel to communicate with your technical reviewer. Clearly NMPA rejected your justification. During the consultation, especially if deficiencies are important ones, we usually bring them up at the 1st out of 3+1 direct consultation and make sure we understand what the reviewer is after and what the key concerns are.
China approved overseas devices are based on their country-of-origin (COO) approval. What you are claiming in your China submission must be consistent with your COO approval. Hardware change is considered a major change in China. You can have your China version of IFU to include what are specific to your China approval. IFU final version should be submitted and approved as well as IFU is an important piece of your change or new modification.
Hard to get multiple of your questions with one simple text. Please feel free to email me if you need further discussions at gpalma@ChinaMedDevice.com
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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?