first, look into your contract with your agent and see if there is anything you can do to speedup the process (any penalty stipulated in your original contract). second, if you prefer, you can change your China agent at this time but it is a separate change procedure to get through. Also, the change does not stop the clock on CMDE side so you need to watch your time closely.
------------------------------
Xiaoyun He RAC
Depuy Synthes
Raynham MA
United States
------------------------------
Original Message:
Sent: 28-May-2017 19:39
From: Grace Fu Palma
Subject: China registration and legal agent
You can replace your CFDA legal agent during the registration phase. If you are on the final stages of submission, I assume that you have received the 1st supplement notice and ready to address the supplement questions. This is a very critical phase. You have one year to prepare and file. We have dealt with this type of situations before for clients similar in your situation. Please give me a call and email me as I need more information to determine where you are and find an optimum solution for you.
Grace
------------------------------
Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com
978-390-4453
www.chinameddevice.com
------------------------------
Original Message:
Sent: 25-May-2017 23:45
From: Anonymous Member
Subject: China registration and legal agent
This message was posted by a user wishing to remain anonymous
Hi,
If the legal agent in China who is responsible for all the regulatory activities delays the registration , what can be done ? Especially if we are on the final stages of submission and the legal agent doesn't provide any feedback and its difficult /too late to go through the process with another legal agent ? Has anybody experienced such a situation ?
Thanks ,