Reporting Significant Medical Device Changes to Argentina's ANMAT

Q

QECarrie

#1
Hi All,
I've been viewing these forums for a while and have found lots of useful information about world wide regulations and registrations. So thanks to everyone who posts here!:)

I'm looking for some advice about reporting a significant change to our registered medical device to ANMAT. Does anyone know if significant changes need to be reported? And if so, what is the process for doing this? We currently have three distributors registered to sell our products in Argentina.

Many Thanks in advance
 
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E

evilchilli_420

#2
Re: Reporting Significant Medical Device Changes to ANMAT

What is the significant change that's being made to your devices? Our distributor helps us report significant changes to ANMAT and we have provided documents as needed. You can work with your distributor and identify if your change is reportable or not.
 
Q

QECarrie

#3
Re: Reporting Significant Medical Device Changes to ANMAT

Thanks Evilvhilli_420 - the significant change is a change in the device software that is being corrected due to a FSCA.
 

MDD_QNA

Involved In Discussions
#4
Does anyone have any information on the medical device regulation in Argentina? Is there any possibility to import any device before it is registered? I've heard that under a number of devices (for instance 3-4 devices) can be imported without registering them and then after that number you have to register. Is that heresay?
 
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