SFDA/CFDA Shortend Registration Appendixes

Q

q-cell

#1
Dear forum collegues,

We are a manufacturer of small dental instruments, which differ not much from each other regarding medical functionality, material, shape and size. Many products of our company were registered by SFDA - this registration is valid until the end of the year 2015.

Unfortunately, many of the applied (e.g. 1500) class-2-products were not mentioned in the final registration list given as an attachment to the registration certificate. We do not know why SFDA shortened the applied list. No comment was given on request. As an alternative a new registration period (lasting env. 15 months!) for "the lost ones" was proposed.

Nevertheless this had so far no importance for deliveries to China.

Newly the customs crosschecked the individual product designation and found items which are not on the registration list. The delivery was stopped at the Chinese customs.

Does anybody know how to deal with such an occurence?

Same problem: In a registration-period of e.g. 5 years many manufacturers develop ?new? products (with minor changes and improvements but equal functions) very similar to the registered products and label them consistently different from the registered ones. As these ?new? products are not on the registration list (which might be e.g. 4 years old) and can therefore not imported in China without an additionally registration procedure.

Does somebody know any method to come legally out of this conflict (which is faced to many manufacturers)??
 
Elsmar Forum Sponsor
T

treesei

#3
The party you hired to register your products in China should take the responsibility of communicating with the CFDA. Five year sounds unusually long. However, during the 5 years there should be opportunities to submit revised product specs to reflect changes that may occur. Some companies adjust their internal product system to cope with the problem when the product version changes during the China registration process or take the re-registration route. It is extremely important to keep good communication with the Chinese agent and the CFDA and never let the ball drop.
 
Q

q-cell

#4
Yes, communication with CFDA is the key-issue.

But probably good news came along - this could be very helpful.

As I’m not allowed to give links, pls. search the keywords on google
[1]


“MassDevice” + “Chinese regulators to launch simplified registration renewal process in 2014“

[2] Therein is a link to a CFA notice.
Is a native cn-language speaker able to verify this ?

Are the details in [1] covered by [2] ?


 
T

treesei

#5
Covered. Of course when you do the real work, you still need to figure out the details. Good luck!
 
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