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GLM12345
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!