Re: Refurbished class 2 medical device which were returned because of 'Customer Remor
Hello,
I was trying to find any inormation about refurbishment on Google, but I failed. I found some information, but I have still some questions.
I think, my questions are very close to topic of this thread. That?s why I would like to continue with this threat and not to start a new one.
Our company is foreign manufacturer of Medical Devices class 2. We have our Agent in and Initial Importer in US.
Our company (manufacturer) provides also Servicing at the moment.
We would like also to refurbish older devices returned from customers and after then to sell it. Refurbishment will be done by our company. We don?t need third party or cooperative other companies.
1. I think we are not required to change status of our Company in FDA registration. But, I am not sure. Should we take any action towards FDA?
2. I think the only what we should do is to establish adequate SOP and keep traceability. I mean that there should be full history of the refurbished medical device in our (manuacturer) agenda, e.g. sold to the first customer (who, when etc.), device return on, device refurbished on, device sold (who, when etc.). Am I right?
3. Should we change labeling of refurbished device?
a. Should we change Serial Number?
b. Should we make a new labeling?
c. Can we use the same type of label, just to change e.g. Serial Number?
d. Should be there any note that unit is refurbished on the new label?
We have to also be compliant with ISO 13485, that?s why I have the same question also from ISO 13485 point of view.