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Device Registration Ammendments - Modifications to Medical Devices

#1
I work for a US device manufacturer and oversee many projects that require modifications to devices. The devices have already been registered in the countries which we are now releasing the modification into. It's unclear (other than reading every country regulation under the sun) what the triggers are (most common triggers) for a registration to be ammended. We sometimes generate new CAT numbers (used for customer ordering only) for components of the device. I am not convinced that a change at this level warrants a re-registration, if we re-registered each time we got new CAT numbers, we'd be out of business due to reg costs. My research has shown that its a change in product name, label, intended use, device class, P/N (maybe)? Hopefully, there is someone who can provide more information, a resources/ guidance and best way to approach. Thank you!
 

mare1

Starting to get Involved
#4
Thank youl - I am trying to find out what the specific regualtions are in Brazil, and when they feel an ammendment is required
There is another thread which might help you: Reporting Changes to ANVISA: elsmar.com/elsmarqualityforum/threads/reporting-changes-to-anvisa.64901/
 


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