Registration veterinary medical device (laser) requirements

Aliken

Registered
#1
Hello Everybody,

We want to market veterinary medical device (laser) in several countries worldwide.
Does anybody know are there any registration (regulatory) requirements for such device in the following countries:
China; S. Korea; Taiwan; India; Thailand; Brazil; Mexico; Japan; Argentina and Uruguay.
I tried to contact these authorities via contact addresses I found on their respective MoH websites or even call some of them but didn't get any response/info.
If anybody has any experience with these countries, please let me know.
Thank you,
Daniel
 
Elsmar Forum Sponsor
#2
Hello,
I am working as a medical device consultant in S.Korea.
Veterinary medical device (laser) is under the ANIMAL AND PLANT QUARANTINE AGENCY Korea.

There are some different procedure in Veterinary medical device.

Regarding inquires, please email to [email protected]
Thanks.
 

Ronen E

Problem Solver
Moderator
#3
I can't say much about the requirements in any of these countries, but my limited experience with veterinary devices in other countries indicates that in most cases there are little to no premarket requirements that apply directly to the manufacturer. Typically any applicable regulations speak of owner/operator (clinic etc.) obligations, e.g. registration/licensing of X-ray equipment with state authorities.
 
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