Is it possible to change IFU only for China?

Hi everyone!

For a medical device registered under MDD that a manufacturer wants to register in China: would it be possible to change IFU only for China?

Would it be necessary to do a modification in Europe to also include those new IFU, or is it possible to just present a different IFU (from the one approved in EU) during the Chinese registration? Thank you.

Just create a new IFU version just for the Chinese market.

Shimon

Franky Zhang123 said:

would it be possible to change IFU only for China?
Yes. You can create a new IFU version just for the Chinese market.
Would it be necessary to do a modification in Europe to also include those new IFU, or is it possible to just present a different IFU (from the one approved in EU) during the Chinese registration?
It is just present a different IFU (from the one approved in EU) during the Chinese registration.

Click to expand...

Thanks for the answer!

Just to be clear, it is NOT necessary then to have that new/Chinese IFU version registered in EU?

In that case, would the manufacturer have to remove the CE marking from the labels/leaflets/etc in China, as that new/Chinese IFU is not registered under the CE marking?

Correct, you don't need to register the new China IFU in the EU market.
And you should remove the CE marking form China labeling.

shimonv said:

Correct, you don't need to register the new China IFU in the EU market.
And you should remove the CE marking form China labeling.

Click to expand...

Hi Shimon! Thank you for the answer!

Sorry to get back to this post, but I have heard from a supposedly reliable source close to my company that it is not possible to modify the IFU only for China, as for registration the NMPA requires COO approval and in Europe that means CE marking.

I guess their logic is that, if the NMPA requires COO approval (CE marking), and if you modify the IFU of a product, that variant (with the modified IFU) is technically not registered in EU and does not have a CE marking (because it is a modified variant from the original product).

And so that means that you cannot register it in China, as that variant is technically not CE marked.

Sorry if the text is a bit confusing. I personally think it makes sense, but at the same time I know that companies do usually modify the IFU without any problems (and I also got your's and Frankys comments...).

I suppose that the inconvenient would be if the NMPA audits/reviews the original product documentation (the one that is CE marked) and they realize that the IFU has been modified for China.

What do you think? Does it make sense?

Might be best to pose this query to your NB industry rep. I suspect most EU NB dont have an opinion on devices intended to be sold into China.

Ed Panek said:

Might be best to pose this query to your NB industry rep. I suspect most EU NB dont have an opinion on devices intended to be sold into China.

Click to expand...

Hi Ed, thank you for the reply!

You mean ask our European NB? Wouldn't this be more related to Chinese authorities, as it would be "in breach" of its standards (as the device to be registered in China with the new IFU wouldn't technically be CE marked...). Or am I missing something?

This is hard to answer without knowing what exactly the modification is. I think this also depends on how you implement this variant.

How will the Chinese version be different from the EU version? Are you referring only to additional China-specific information like the Chinese authorized agent, Chinese registration number, etc or are you intending to have a specific subset of indications/instructions that are ONLY for China?

Personally I've never heard the point that you mentioned where the China version is not "technically" approved in the EU. If you give the Chinese version of the pump a different number entirely, it is indeed true that that specific catalog number would not be considered to be approved in the EU (and in that case it should NOT have the CE mark).
However, this is such an easy question to address in the submission... simply add a comparison table that compares the "EU" and "China" version that shows that the devices are identical in all ways except the IFU. If the ONLY difference is the part number I personally do not think this is a significant issue for the submission/approval.

If you are proposing to add indications or significantly change the Chinese indications from the EU version such that it changes the actual technical content of the submission, I think that is where you will run into an issue.
If the only difference between the Chinese IFU and the EU IFU is the language and additional China specific content, I personally have not run into an issue with that particular version not being cleared in the EU. In my experience, overlabeling in China to add additional labeling is extremely common. If you have an agent/distributor who will add the IFU and Chinese label to the packaging once it is in China, you don't need to change the part number at all.

IS1027 said:

Hi Emilia!

Everything you say makes perfect sense considering the info. I provided.

Sorry, I should have definitely gave more details.

What was being considered to be changed for China were the indications of the medical device. Basically, with the current indications (the clinical condition that the device treats) the device was being classified as a drug in China, and not a medical device. So the idea was to "tone down" the indications just for China: instead of saying that the device treats X condition/illness, for China it was going to say that it treats X discomfort (basically removing the illness factor). Specifically, in Europe the indications are for "dry eye", and in China it would be for "eye discomfort".

From the European perspective the change doesn't seem massive, in fact, it would be toning down/removing severity, but it would still mean modifying the indications nonetheless, and that was my concern.

Click to expand...

So yeah, this information totally changes the situation. The IFU version is a red herring here. Do you have the information to support this limited indication for China? Regardless of whether it is approved in EU or not, you have to ensure that the rest of the information you'll present in the submission supports this indication.

i think you need ask medical background person who understand the Chinese words. I saw too much indications translated into Chinese with wrong meaning, which cause misunderstanding of CMDE