CB Certificate and IEC 60601-1 Test Report requirements - Korea Product Registration

Z

zhang126

#1
Hi !

Does anyone know if both CB certificate and IEC 60601-1 test report are required in Korea for product registration?

Thanks!
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: CB Certificate and IEC 60601-1 Test Report requirements - Korea Product Registrat

For what product?
 
Z

zhang126

#3
Re: CB Certificate and IEC 60601-1 Test Report requirements - Korea Product Registrat

electric medical devices in general
 

sreenu927

Quite Involved in Discussions
#4
Re: CB Certificate and IEC 60601-1 Test Report requirements - Korea Product Registrat

Hi Zhang126,

For product registration in Korea, the document requirements depend on the Classification of the device.

However, both CB Test Report and CB Test Certificate are required as part of the objective evidence for Electrical Safety Testing.
Even for the Instrument's Power Supply they require the Electrical safety Test report and CB Certificate.

If you have only report , not the CB Cert, then KTL (Korean Type Testing Labs) will conduct some additional testing in Korea, that may cost some more and may slightly delay the registration process.

Regards,
Sreenu
 
Z

zhang126

#5
Re: CB Certificate and IEC 60601-1 Test Report requirements - Korea Product Registrat

Thanks! this is good enough!
 

swathi.sp

Starting to get Involved
#6
Hi,

Further to above information, we are manufacturing Electrical Medical devices (Radiotherapy & Radiology products). And we have IEC informative test report but not CB scheme. As there are no national differences in Korea , IEC informative test report will be in suffice to register for KFDA.

Please let us know on this
 

Sicco

Involved In Discussions
#7
My experience is that they always require testing for national differences in CB testing.
It means power cords with plugs according to local standard and testing under local power specifications - 220V and 60Hz.
 
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