CFDA Clinical Evaluation Report (China)

[Gamula]

Hi Elsmar Cove Users,

as we all know the CFDA is a challenge: unpredictable, intransparent and takes loads of work. That´s the reason why we like it or not

I would like to talk about the clinical evaluation that should and could be a short cut to avoid clinical trials. Unfortunately, nobody knows whether this will be accepted by the CFDA for foreign manufacturer.

Does anyone have any experience regarding their clinical evaluation report. Was it successful?

Did anyone decide to not write it because a clinical trial is more probable to be approved by the CFDA, although, it takes at least one year to have the trials´results.

There are numerous open issues and I think that this is of everybodies interest.

for any reaction!!!

With best regards
an arab-german regulatory affairs manager

 

[shimonv]

Re: CFDA Clinical Evaluation Report

Hello Gamula and welcome to the cove,
You did not provide real data to go on, but I will try to answer based on my experience working with my Chinese regulatory partner and friend.

Does anyone have any experience regarding their clinical evaluation report. Was it sucessful?

I am not aware of an accepted clinical evaluation report in the product family that I have been working on. It doesn't mean it's not possible, but based on our talk with the CFDA reviewer it has to be really good. Ironically (and typical CFDA) even the reviews don't have a clear idea of what's acceptable and what's not. It's a new regulation and would take some time to 'stabilize'. In such cases the best advise I can give you is to work closely with the reviewer (frequent visits).

Did anyone decide to not write it because a clinical trial is more probable to be approved by the CFDA, although, it takes at least one year to have the trials´results.

That was the conclusion I came to with one of the products I have been working on. I read the guidance document carefully, considered what we have and realized that we don't have what it takes (too many gaps).


-Shimon

By the way, a trial can be shorter than a year. It depends what you are doing, with whom, where, when, etc.

 

[Gamula]

Re: CFDA Clinical Evaluation Report

Dear Shimon,

First of all, THANK YOU VERY VERY MUCH!!
I am working with MDD class 2a/b devices which will be class 3 according to the CFDA regulations. I am working with a regulatory agency locally based in China / Beijing. The devices are dental devices.
Your idea of waiting and letting the CFDA reviewers stabilize is not an option for my boss. But, the reviewers visits are one option with any output before getting the CER rejected at least.
Nobody is aware of any successful CER i.e. eluding a CT. I am writing since one year. Result: ~100 pages (without annex that would be additional 200 pages) and I am sitting in the darkness of ignorance

BUT, the most interesting CFDA coup is the equivalent device data. Beside the CFDA database and experts on the market for just finding the equivalent devices, the data necessary for the CER is overwhelming in obtaining. Section 4 of the CER is only about the equivalent devices - I even put for every device two equivalent devices. If there is anything usable than we were told to officially ask the manufacturer for approval for the data. I did not try it due to strategic reasons and I assume that it won´t be successful. I only put the URL, date and time into it - as done in scientific articles. Even scientific articles from CNKI / China Academic Journals Full-text Database is really hard to get. How do you manage the data from similar devices for your CERs of CFDA class III ? Because the literature search is not explained in detail.

In other words, this regulation is a unfinished good approach form the CFDA and I think it will be amended after the fist rejections. What do you think?

With best regards
Gamula

 

[shimonv]

Re: CFDA Clinical Evaluation Report

Hi Gamula,
I can see that you are going through the same thought process than I did...

CFDA officials created a guidance that makes the EU CER looks like a kids game.
Since we are talking about China the same rules of logic as with the US FDA do no apply, unfortunately. There might be other interests at play except regulatory. I don't know.
Now, clinical litrature is tough (almost impossible) to get when you need to ask your competitors for help. But I think the more difficult challenge is to provide clinical experience by comparing your device against the equivalent device which also addresses the areas of differences between the two.
This is crazy unless the equivalent device is also yours!!

Let me make it simple for you: if you have not done a clinical trail elsewhere in the globe, don't even bother to go down this path. If you have your own clinical data and care to befriend the reviewer - the chances are slim but doable. You could tell stories to your grandchildren.

I suspect you will need to focus your efforts on finding a good partner for clinical trials in China in terms of cost and time to complete. If you tell what the device is I can check with my contact in Chinese if he could do it.

BR,
Shimon

 

[Gamula]

Re: CFDA Clinical Evaluation Report

Dear Shimon,

thank you for your compassion . I hope that I will see it through your eyes soon.

Nevertheless, we have to face it and you are completely right: This is crazy!

We have numerous article of the devices and we got way more case studies. We got loads of "clinical data", but no complete clinical trial data with ethics comittee approval. This is an issue which can cause a rejectby the CFDA and we have to roll up everything from the beginning including a clinical trial.

I have been talking about this issue with our Head of RA. Event about the conversation we have here togehter with the option of your support. She did decide not to try your offer due to strategic reasons, again. However, there may be a day in the near future when we cannot try to avoid a CT because we need to sell, regardless of what it costs.

We got 7 groups where this one has class III, the others are class II and class I. The CERs of lower classes are easily done. BUT, there is also an very interesting issue with the CFDA: Some devices could be exemptions accoording an announcement. It is from the medical device regulatory service provider that we all know. Read the post with the following headline:

New Chinese FDA List of Medical Devices Exempt from Clinical Trial Requirements

As you know, links are tricky here.

Now, my contact in China is evaluating this whether it is realistic to go this way with some devices. We are still waiting. Have you been aware of this?

Last but not least, we have tried to go through Taiwan with its registration, no chance. Now we add our european clinical evaluation to the CFDA CER for class III.

The toughest issue will be compensation the passion and money we put into it, if it is rejected.

Now, did you receive a acceptance letter after submission including your CFDA CER? I am curious about this.

With best regards
Jamil