SFDA Approval (China) - Changing Locations

C

Cinti

#1
Hi,

We got SFDA, China's approval for one of our product. During registration, we shifted our manufacturing facility to the new location. It is situated about 7 kms away from our old facility. We started registration in old facility and hence we received registration approval certificate with old facility address. Kindly let me to know the procedure for changing address in the certificate.

Usha
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Hopefully one of the others here will reply, but my *assumption* is that when you move from one facility to another you will have to go through an audit in the new facility. I don't *think* it's going to be a simple matter of changing the address on the certificate.
 

Ajit Basrur

Staff member
Admin
#3
Hi,

We got SFDA, China's approval for one of our product. During registration, we shifted our manufacturing facility to the new location. It is situated about 7 kms away from our old facility. We started registration in old facility and hence we received registration approval certificate with old facility address. Kindly let me to know the procedure for changing address in the certificate.

Usha
Hi Usha,

All Product registration are usually valid for 4 years. In order to change manufacturing locations or add a new manufacturing location, a new product registration must be submitted.
 

yodon

Staff member
Super Moderator
#5
I won't profess to be an expert here, but we had a client that did just that and the FDA *did* require a re-inspection.
 
B

babarian

#6
Hi,

We got SFDA, China's approval for one of our product. During registration, we shifted our manufacturing facility to the new location. It is situated about 7 kms away from our old facility. We started registration in old facility and hence we received registration approval certificate with old facility address. Kindly let me to know the procedure for changing address in the certificate.

Usha
hello Usha:
hope you get your lincese updated now because it will take a long time.
normally one year if it is all right.
best regards,
Fan
 
E

Erik_

#7
I just registered after a long time leeching in the background to say thanks for your advise and to join the discussion. My employer plans to move production to a different location as well. It is also planned to change the legal manufacurer and the article numbers. Now we learnt, and Ajit confirmed it, that the LM change or new article numbers would be an ammendment which would take about 6 months. However, the transfer would require a re-registration (2+ years). I found a shortcut to the "State Council: Medical Devices Administration Regulations" here in this forum. (as my post count is <5 I cannot insert it)
Article 13 states "In case any situation reflected in the content of the registration certificate is changed, the holder of the certificate shall apply for an amendment of the certificate accordingly, or for re-registration within 30 working days from the change"
Does anyone could point me to the source were "amendment" and "re-registration" are defined?

In any case, I hope I can learn and contribute in the future.
Erik
 
E

Erik_

#9
Dear sunny,

Thanks a lot for your feedback. However, by means of google translate I was able to identify two applicable sections of the SFDA Board Order No. 16. Sorry for not providing any links, but as a new subscriber I cannot include them:
Chapter re-registration of medical devices

34 certificate of registration of medical devices in the following changes, changes in manufacturing enterprises shall, within 30 days from the date of application for re-registration changes:
(A) of the models, specifications;
(B) the production of address;
(C) product standards;
(D) the structure and composition of product performance;
(E) The scope of products.
[...]

Chapter VI Medical Device Registration Certificate of the changes and re-submit

38 certificate of registration of medical devices contained in the contents of the following changes, changes in manufacturing enterprises shall, within 30 days from the date of application for certificate of registration of medical devices to change:
(A) the production of the same business entity, corporate name changes;
(B) change the registered address of manufacturer;
(C) production of the text of the address change;
(D) the product name, trade name of the text of the change;
(E) models, specifications, the text of the change;
(F) the name of product standards or code of the text of the change;
(G) an agent to change;
(H) changes in service sector.
I think your advise relates to 38 B which, in my understanding, is more or less a change of the legal manufacturer (or its official address). However, 34 B relates to the actual manufacturing facility. Which means, in my current understanding, that a production transfer requires a reregistration. But as 6 months or 2 years make a big difference, we are still trying to find ways to easen the burden (building up stock, parallel production, ...).

Caveat: This is a machine translation. So subtle differences in wording are lost.

Erik
 
S

sunny093

#10
Hi Erik,

You are right.If the OEM address is changed,it will be trigger a SFDA re-registeration and it will take about 2 years.But if only th legal manufacture address is changed,it will not take so long time.I am sorry for my careless for do not see details of your question.

Sunny
 
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