Impact of changing ISO 13485 registrar / notified body on Chinese SFDA approval

M

MichaelSch.

#1
Hi members of the elsmar cove,

I have a question regarding the SFDA approval in China. I would like to know, what has to be done to keep Chinese approval when changing our notified body / ISO 13485:2003 registrar.

There will be some changes in the QMS, because the company consists of two parts that have not the same NB and not the same QMS, which shall both change in the nearer future. Products will stay the same.

I read another thread here on elsmar cove regarding changes in e. g. models, adresses and so on, but there is no hint what has to be done when changing the registrar.

It would be great, if you could help me out on that problem and could tell me, what has to be done and if there is a possibility to do it without a re-registration. If a re-registration or something is neede, it would be great if you could tell me how long it will approximately take.

Thank you all,

best regards,

Michael
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hi members of the elsmar cove,

I have a question regarding the SFDA approval in China. I would like to know, what has to be done to keep Chinese approval when changing our notified body / ISO 13485:2003 registrar.

There will be some changes in the QMS, because the company consists of two parts that have not the same NB and not the same QMS, which shall both change in the nearer future. Products will stay the same.

I read another thread here on elsmar cove regarding changes in e. g. models, addresses and so on, but there is no hint what has to be done when changing the registrar.

It would be great, if you could help me out on that problem and could tell me, what has to be done and if there is a possibility to do it without a re-registration. If a re-registration or something is needed, it would be great if you could tell me how long it will approximately take.

Thank you all,

Best regards,

Michael
Can someone help Michael with this?

Thank you!!

Stijloor.
 
M

MichaelSch.

#4
Thank you for that hint! I will read over it tomorrow and if I find the answer to my questions there, I will let you know.

Best regards,

Michael
 
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