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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!
 
#5
It will vary greatly depending on the country. For your specific example, some countries will require every sku imported to be on the device license. Sometimes the invoice also has to match the registration to clear customs. Therefore, if you have a "virtual sku" (i.e. one that only exists for ordering purposes) your invoice might not match what is registered. Also, if you change the sku/part number there are many countries that will require an update to the license, even if there is no change to product. This is usually part of your registered details that, if changed, require updates. My recommendation has always been to every company I have worked for is "Dont change the product model number/sku unless you absolutely have to." The effect globally almost always makes it a losing effort. I would recommend creating a "configuration ID" that can differentiate different configurations of the same product. Its essentially a revision of your configuration that isn't specifically built into your core product number. I worked at one company that was particularly good at this. They could have a different configuration (lets say one that has a unique in package IFU) and another one that is the rest of world configuration both with the same part number (example 1234-01 and 1234-02) but the REF would just say 1234. My current company, on the other hand, really struggles with this as it is all or none. The only way to track differences or changes is via a new lot. It creates havoc trying to control product when you have reportable changes.

Hope this helps.
 
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