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Leveraging FDA 510k Clearance for International Registrations

J

justinjackson

Registered
#1
#1
Hi all,

I was curious if anyone has had success leveraging FDA 510k clearance (No CE mark) for the following jurisdictions :

- South Korea
- Japan
- Israel
- Kuwait

Thanks in advance!

Justin
 
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S

Sicco

Involved In Discussions
#2
#2
Even the EC Certificate is worthless for certification in Korea and Japan, these countries have their own certification system based on different requirements.

With Israel and Kuwait I have not enough experiences.
 
J

justinjackson

Registered
#3
#3
Sicco said:
Even the EC Certificate is worthless for certification in Korea and Japan, these countries have their own certification system based on different requirements.

With Israel and Kuwait I have not enough experiences.
Click to expand...
Thanks for your input! I've come across a similar understanding for Korea and Japan as well. Curious about the rest....
 
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