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

shimonv

shimonv

Trusted Information Resource
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
 

Attachments

  • Technical Guidelines for Clinical Evaluation on Medical Devices.pdf
    316.1 KB · Views: 584
L

LFZR88

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

shimonv

Trusted Information Resource
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
 
L

LFZR88

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

shimonv

Trusted Information Resource
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
 
W

wfong3

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

shimonv

Trusted Information Resource
wfong3 said:
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
Click to expand...

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
 
J

jawlong

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
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L How to find a good online CFDA submission training? China Medical Device Regulations 5
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
J Change management with CFDA approved devices China Medical Device Regulations 1
Marc China - CFDA is now National Medical Products Administration or NMPA China Medical Device Regulations 7
Gamula CFDA Biological Evaluation Report China Medical Device Regulations 2
N China's CFDA - Medical Device Validation Requirements China Medical Device Regulations 8
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
E RF Energy Treatment Devices for CFDA Registration China Medical Device Regulations 1
O CFDA (China Food and Drugs Administration) Audit Finding Classifications China Medical Device Regulations 1
R CFDA submission fees as of May 2015 China Medical Device Regulations 4
Y Is CFDA registration required if the full system is registered by our distributors? China Medical Device Regulations 2
Y Is it possible to check the authenticity of a CFDA registration certificate? China Medical Device Regulations 7
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
P Is an English version of CFDA YY0664-2008 available? China Medical Device Regulations 3
J CFDA issues Guiding Opinions on Enhancing the Construction of Food and Drug Inspectio China Medical Device Regulations 1
A CFDA - List of Class II Medical Devices exempt from Clinical Trials China Medical Device Regulations 2
R CFDA updated five regulations to be effective from October 1, 2014 China Medical Device Regulations 16
C CFDA announced 120 new Medical Device Standards - July 2014 China Medical Device Regulations 0
C CFDA MD regulation_20140331 - Comes into effect June 01, 2014 China Medical Device Regulations 33
pittmatj CFDA Requests Biocompatibility Evaluation for Raw Materials ISO 13485:2016 - Medical Device Quality Management Systems 6
B Amending Registration with CFDA due to Change in Site of Manufacture China Medical Device Regulations 3
M How to communicate the change in company address to CFDA ? China Medical Device Regulations 1
T CFDA seeks for public comments on newly revised medical device classification rules China Medical Device Regulations 1
T CFDA Simplifies Medical Device Re-Registration Process China Medical Device Regulations 1
Q SFDA/CFDA Shortend Registration Appendixes China Medical Device Regulations 4
T The CFDA recently issued new Medical Device Industry Standards China Medical Device Regulations 0
T CFDA issued second list of Class II devices exempt from clinical studies (10/11/13) China Medical Device Regulations 4
T CFDA recently classified 23 products (9/27/13) China Medical Device Regulations 5
T CFDA issues notice for Small Oxygen Respirators (9/16/2013) China Medical Device Regulations 0
S SFDA (China's state Food and Drug Administration) changed to CFDA China Medical Device Regulations 6
A Will EU MDR Notifying Body CER and CEP Technical documents Other Medical Device Related Standards 1
P Bankruptcy Provisions for availability of Technical Documentation EU Medical Device Regulations 5
P Technical File - Device Familly & Accessory EU Medical Device Regulations 1
B Technical Documentation EU Medical Device Regulations 4
G Format of Technical File template and GHTF/SG1/N011:2008 ISO 13485:2016 - Medical Device Quality Management Systems 10
A MDR- Technical Documents EU Medical Device Regulations 4
M Should DoC be updated every time Technical Documentation is revised? EU Medical Device Regulations 2
D Can a contract manufacturer own the technical file EU Medical Device Regulations 1
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
Pmarszal Technical File - Critical Supplier List Questions CE Marking (Conformité Européene) / CB Scheme 2
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 3
E Discussion: How do you split up your Technical Documentation? EU Medical Device Regulations 4
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
S Assembling technical file for a medical device ISO 13485:2016 - Medical Device Quality Management Systems 1
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
G Technical documentation for UKCA UK Medical Device Regulations 4
A Technical Documentation => Responsibilities when signing documents ISO 13485:2016 - Medical Device Quality Management Systems 7
A Update of Technical Documentation EU Medical Device Regulations 3

Similar threads

Top Bottom