Labeling language regulation China vs. CE/MDD

D

dcraig

As many of you who import product into China know the new labeling language requirements take effect April 2013. All of our products are CE marked and the customer wants to maintain the CE mark on the product we are importing. We are currently in the process of ammending our labeling to meet the new requirements for China. My questions is how are you dealing with the language issue for labels as far as China vs CE/MDD? China requires labeling be in all Chinese upon entry to the country yet our CE labeling is in English. My understanding is that we cannot just have the label in Chinese and have the CE mark even if the symbols are maintained. Does anyone have a different interpretation of the MDD that would allow us to have labeling in all Chinese? I am struggling to find a way to justify this which means, due to the size of the product (small), having either 2 inserts or the package label in Chinese and an insert in English to meet CE requirements. Thanks for any input you may have.
 
S

ssz102

both chinese and english are adding to the labeling together, it's ok?
 

Ronen E

Problem Solver
Moderator
The CE mark is the manufacturer's declaration that all EC requirements are complied with when the product is placed on the EC market. The product you place on the EC market must comply 100%. Similar products with different labelling (e.g. all-Chinese) that are not placed on the EC market, don't have to be in 100% EC-compliance, and the fact that they show the CE mark shouldn't bother anyone - IMO - as long as they don't enter the EC (assuming you are outside the EC).

This is all from an EC perspective. If I were you I would double-check that the Chinese system has no issue with this CE mark.

Of course, the above approach would require carrying at least 2 different versions - one for the EC and one for China.

Cheers,
Ronen.
 
M

MIREGMGR

China requires labeling be in all Chinese upon entry to the country yet our CE labeling is in English. My understanding is that we cannot just have the label in Chinese and have the CE mark even if the symbols are maintained. Does anyone have a different interpretation of the MDD that would allow us to have labeling in all Chinese?

If I understand you correctly, you think the SFDA final rule requires Chinese text content and no other text content.

I do not read Chinese, but my understanding is that the rule requires Chinese text content in addition to whatever other-language text content the manufacturer provides.

Not that it's definitive, but the consulting firm Pacific Bridge Medical agrees with this understanding. See their website: http://www.pacificbridgemedical.com...ol-over-labeling-of-imported-medical-devices/

(I'm not recommending them, or the opposite, and I have no affiliation. They are just a conveniently available resource for the question at hand.)
 
D

dcraig

Actually the opposite I am worried about of MB not SFDA. The SFDA requires the labels be in Chinese but we do not have room for both English and Chinese on our label. SFDA I believe is fine with having both English and Chinese or just Chinese. I am wondering if we can continue to apply the CE mark if the label is in all Chinese other then the ISO 15223 symbols? Looking to get an answer before we spend a lot of time doing this only to have our NB say no. Thanks
 
Z

zhang126

If a medical device bears a CE-mark this product must comply with MDD 100% no matter where it will be placed, inside or outside of EU. I am quite sure about this from some EC guidance/document but I just could not remember the source. I may come back with the source when I find it.

The Chinese SFDA requires labels in Chinese with or without other language on/with the devices imported into China. CE-mark on the label is OK for SFDA and OK for EC only when the device fully complies with MDD.
 

Java23

Involved In Discussions
Hi - it seems clear to me that product and package labeling and the IFU will need to be in Chinese or Chinese/English. I am having some difficultly in understanding what do you when it comes to the actual product.

For instance, our product, which is used in medical facilities is color coded in accordance with ISO. The product is used with different types of gasses and is color coded as such.

The respective type of gas is stamped on the product in CAPS. For instance, VAC. We have been informed via a customer that China will not permit VAC (caps) and will only accept (Vac) Upper V and lower ac.

I am not clear as to why the caps vs. non-caps would make a difference and was wondering if anyone could help me out and teach me something here?? Thank you in advance for your input/comments.:thanks:
 
M

MIREGMGR

Either "VAC" or "Vac" is an abbreviation in English, and (obviously) is text.

We have been informed via a customer that (...)

I'm surprised that China would not want a text label to be in Chinese in addition to English.
 

Java23

Involved In Discussions
Thats what we were thinking - then again???? I am still learning some of our products. While the hoses (which are the product in question) are used with medical devices, they are not sold with the devices - they are considered accessories per our ISO Certification. Does anyone know if the labeling requirement is for ANY (medical or non medical device) product imported into China? End of day...........my brain hurts :) Thank you!
 

Ronen E

Problem Solver
Moderator
Please mind the language and culture gaps. I would have conducted an independent check with the source (regulations), and if these can't be found in English (authorized translation) I would seek the assistance of a local who is very good with English. Perhaps contact Emergo China (no affiliation here) or the like.

I'd never rely on a single customer as a sole source on regulations. Of course they can require whatever they like, but that's a bit different to the "sorry, our hands are tied" implication of a regulation.

Cheers,
Ronen.
 
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