IVD registration renewal in China

#1
Hi everyone,
We have an ELISA kit registered in China as an IVD since more than 4 years. It is time to renew the registration, but I can´t find any regulations or guidelines in English to help me understand the process. In fact I don´t find any Chinese regulations or guidelines in English. I thought I would be able to find the information on the NMPA web site, but I have failed. Can anyone advice me how to find the current regulations/guidelines?

I would also like to find information of how to report a design change in China, but I end up with the same problem, that I can´t find the information. Any input appreciated.
 
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shimonv

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#2
Hi Jade,
The NMPA website is not very useful. It was built layers upon layers by different groups. New publications are not readily available in English.
You will need to work with a local partner to get answers to your questions and to prepare the application file in Chinese.
If you'd consider working with a consultant, please contact me privately.

Shimon
 
#3
Thank you for your prompt reply!
I was afraid of that. It is frustrating not to have access to the regulations. At this point I would like to get an understanding of the requirements to support the decision if a renewal is worth it or not. Do you have an idea of the amount of documents needed to resend? Is testing needed again?
 

shimonv

Trusted Information Resource
#4
Hi jadestatyn,
1. License renewal is much simpler than a new application and involves a bunch of declarations that there is no change in the device (if this is the case).
2. For license renewal type testing is not required unless there is a change in key component.

Shimon
 
#5
Ok, thanks. If we decice to keep the product unchanged in China, would it be possible to update the article number in the renewal, to separate it from the updated product, or would that be considered a change?
 
#6
Hello Shimon, how to send private message to you and can you share your contact information to me, I want to discuss with you for some issues.

Liang
 
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