CFDA MD regulation_20140331 - Comes into effect June 01, 2014

M

MPiska

#11
Sreenu, thank you for the English translation!

It looks to be a very positive move, both for clarity and streamlining the processes.
Is there any indication of when the "classification catalogue" will be available?

Under the current regulations our devices (anaesthesia machines) require technical and clinical testing within China, however under the new regulation our clinical evaluation report (via the literature route) should suffice based on article 17.

Our technical standards testing (ISO 60601-1, 80601-2-13 etc.) has been performed by Intertek UK who have a sublicence/agreement from UKAS for the ILAC agreement, which is also observed by the CNAS in China.
If I am understanding it corectly, Article 7 of the new regulation should allow this testing to be upheld and valid for use during the registration process with the CFDA.

What is the expectation of the timelines and clauses such as clinical evidence via literature and technical evidence will be upheld?

At this time I do not have any direct contacts to confirm my assumptions with - I don't want to submit documentation and end up waiting 18 months for them to turn around and request a machine for testing to take another 18 months to get tested...

Best Regards,

MP.
 
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pittmatj

Involved In Discussions
#12
Now that it is June 2nd, I haven't seen anything on how the notification process will work for Class I devices. Would someone care to enlighten us?
 
M

MPiska

#14
It appears that a list of Class I devices has surfaced, along with the word document attached in the link from the post above - both attached to this post.

I'd like to assume that this list is just a first publication and that the classification system will allow more than what is listed to be filed rather than registered.


Any further information anyone has from the Chinese CFDA website would be greatly welcomed, the translated website is not being updated as quickly..

MP.
 

Attachments

M

medgar

#15
Hi All

I hear that he CFDA has just issued a statement that they are not able to implement as desired in June so it will be business as usual for the time being. I am looking to source a copy of the statement. Has anyone seen it?
 
M

medgar

#16
Hi All

Here is the link to the CFDA announcement regarding the delay to implementation:

http://www.sfda.gov.cn/WS01/CL1423/100480.html?from=timeline&isappinstalled=0

Although this is in Chinese, I am advised that it indicates although the new regulation was to be released on 01-June-2014, a more detailed registration regulation will be released soon. Until the new detailed regulation has been released, the registration process will remain the same as previous. In addition, the more detailed regulation will offer guidance as to whether clinical trials are required or not.

Does anyone have an alternative interpretation?

Cheers
 
Last edited by a moderator:
L

llz123

#17
Here is the english version of new CFDA MD regulations that I got from a friend.

Regards,
Sreenu
Thanks a lot for english version.
Can anybody assist also with the english version of the List of Class III Medical Devices Exempt from Clinical Trials (draft). If not, may anyone advice if CVC/PICC and angiographic catheters are within this list? What intravascular catheters are within this list?
 
L

llz123

#19
Hi

Here is the list of Class III devices exempted from clinical trial (draft).

There are 3-4 catheters, one is venous catheter tube which may be considered to be PICC/CVC (not sure).

Nothing is mentioned regarding Angiographic catheter

Regards,
Rangani
Great! Thanks a lot.
Another issue. Article 28 of the new regulations says:
The implantable medical device with higher risk should not be manufactured under entrustment. The catalogue of the medical device varieties prohibited for manufacture under entrustment should be formulated, adjusted and published by the Food and Drug Administration Department of the State Council.
Where can we find this catalogue/or draft? it would be better in English, if not- in Chinese
Thanks,
 
O

obiwan612

#20
Hi All,

does anybody have an English version of the documents related to Class I devices.

Thank you for your help
Paolo
 
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