Is Biocompatibility Testing required for Implantable Class III Devices sent to China

R

RKUB38

Hello,
is it necessary to do biocompatibility testings in China for implantable class III devices? we already do them in Europe.
thank you for your help. I've asked some registration agents but each of them says something else and even one of them wants me to pay 500 USD to give me the information!!
thanks
 
Stijloor

Stijloor

Leader
Super Moderator
Re: Is Biocompatibility Testing required for Implantable Class III Devices sent to Ch

A Quick Bump!

Can someone help?

Thank you very much!!
 
R

RKUB38

Re: Is Biocompatibility Testing required for Implantable Class III Devices sent to Ch

:bigwave:

Thank you.
 
T

treesei

Re: Is Biocompatibility Testing required for Implantable Class III Devices sent to Ch

RKUB38 said:
Hello,
is it necessary to do biocompatibility testings in China for implantable class III devices? we already do them in Europe.
thank you for your help. I've asked some registration agents but each of them says something else and even one of them wants me to pay 500 USD to give me the information!!
thanks
Click to expand...

I belive the answer is yes. And the test must be done in China by an accredited lab. I will send you my invoice of $500 later :D.
 
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