CFDA Technical Guidelines for Clinical Evaluation on Medical Devices (English)

shimonv

Trusted Information Resource
#1
Hello Colleagues,
Attached is good english translation for CFDA's Technical Guidelines for Clinical Evaluation on Medical Devices. It become effective since May last year and poses a great deal of challenge to medical device manufactures.
In fact, it's a lot more difficult than the European guidance for CER (MEDDEV 2.7/1 rev.4 ).

I trust it will be helpful for those of you aiming at the China market.

Best,
Shimon
 

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LFZR88

Involved In Discussions
#2
Hello Shimon,
That is really helpful. Thank you very much.

We are currently trying to get answers from the CFDA (through our potential Chinese distributor) as to whether our EU Class IIb metallic anchor requires a clinical trial in China but have had no answer as yet, it has already gone through mechanical testing and for the last year we have been told that the CFDA hasn't made a decision, we found the CFDA drafts of two medical device clinical trial exemption catalogues on class II & III devices and were fairly certain that our device fitted into one of these exemptions. Manufacturers & foreign medical device companies were told to comment on these drafts by June 2015 and then monitor for the final draft, however there has been no news since then, can anyone shed anymore light on this for me?
thank you.
 

shimonv

Trusted Information Resource
#3
Hi LFZR88,
As you very well know - the Chinese system is less organized & transparent than the west. To my knowledge, the clinical trial exemption catalogs are valid and have not changed.

Specifically to your product - every Thursday CFDA has an open day for manufacturers. Have your distributor or a regulatory expert go there, well prepared, and confirm your assumption.



Shimon
 

LFZR88

Involved In Discussions
#4
Hi Shimon,

Many thanks for your reply, I have another question on the comment you made below

- every Thursday CFDA has an open day for manufacturers. Have your distributor or a regulatory expert go there, well prepared, and confirm your assumption.

How does this work? can we get a quick answer this way from the CFDA? how do we know our distributor will be seen?
:thanks:
 

shimonv

Trusted Information Resource
#5
It may sound strange but its very different than with FDA were you can request a pre-submission meeting and everything is super organized and scheduled.

With CFDA its very rare to be able to schedule a meeting in advance. But Thursdays are the 'open day' for the industry. You need to go there and seek audience with the relevant reviewer for your type of product. As always, knowing people helps.
You need to come well prepared so you can get satisfying answers - in your case perhaps a draft CER with comparison to similar approved devices in China, product labeling, etc.

If you can talk to the reviewer - he will answer your questions. If the individual you want is not available you need to try again in the following week.

As I wrote, it sounds a bit strange, but this is how it works and I'm writing from experience through working with colleagues in China.

BR,
Shimon
 
#6
Hi Shimon,
I read from the document that you shared that clinical evaluation is not applicable to IVD. So for IVD we can register without clinical evaluation regardless of the classification? Thank you.

Cheryl
 

shimonv

Trusted Information Resource
#7
Hi Shimon,
I read from the document that you shared that clinical evaluation is not applicable to IVD. So for IVD we can register without clinical evaluation regardless of the classification? Thank you.

Cheryl
Hi Cheryl,
The device classification, function, and the technology it uses dictates the amount of evidence you need to provide in order to demonstrate safety and effectiveness.
Without additional information its hard to say were you are at.

Kind Regards,
Shimon
 
#8
Hi all,
Nice discussion is going on. Thanks for sharing this helpful guideline on CFDA medical device. I had also got this same information from Peterstechnology when I purchased some medical devices. At that time they said how this certification is important for medical devices.
Thank you
 
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