Refurbished class 2 medical device which were returned because of 'Customer Remorse'

T

TLB123

#11
Re: Refurbished class 2 medical device which were returned because of 'Customer Remor

Chris,

Thanks for all your help. This information will help to steer us in the right direction early in the process.:thanx:
 
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C

Chris Ford

#12
Re: Refurbished class 2 medical device which were returned because of 'Customer Remor

Chris,

Thanks for all your help. This information will help to steer us in the right direction early in the process.:thanx:
No problem. Feel free to email or PM me if you have any other questions.
 
S

superman81

#13
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.
 
B

bblbbblb

#14
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.
I would be interested in answers to the questions in this post too, can someone help please?
 
M

MIREGMGR

#15
Re: Refurbished class 2 medical device which were returned because of 'Customer Remor

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?
This response assumes that the device(s) are durable (as opposed to single-use) and non-sterile.

1. If you're already Registered as a Manufacturer, that's it. There is no additional or different Registration for a Refurbisher.
2. I agree with your summary.
3 and a through d. Not necessary. You can if you want, as long as the new label is equally regulatorily compliant.
 
B

bblbbblb

#16
Re: Refurbished class 2 medical device which were returned because of 'Customer Remor

This response assumes that the device(s) are durable (as opposed to single-use) and non-sterile.

1. If you're already Registered as a Manufacturer, that's it. There is no additional or different Registration for a Refurbisher.
2. I agree with your summary.
3 and a through d. Not necessary. You can if you want, as long as the new label is equally regulatorily compliant.
Thanks, that cleared a lot of things up for me!
 
L

lyang

#17
Re: Refurbished class 2 medical device which were returned because of 'Customer Remor

This may help some you answer the question.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM244277.pdf

Third Party Refurbishers/Reconditioners/Servicers of Used Devices
Third party refurbishers, reconditioners, servicers and "as is" resellers of used devices are currently not subject to the requirements of the Quality System regulation. If the district receives an assignment to inspect such an establishment, the district should contact the Office of Compliance, Office of the Director, to determine the current regulatory status of such establishments.
 

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M

MIREGMGR

#18
Re: Refurbished class 2 medical device which were returned because of 'Customer Remor

I suggest that any firm doing device refurbishment/reconditioning/servicing of a nature that FDA might see as affecting safety or effectiveness should not assume that the above "contact headquarters" statement assuredly means that they will not be subject to inspection and requirements.
 
L

lyang

#19
Re: Refurbished class 2 medical device which were returned because of 'Customer Remor

You are absolutely correct. 21 CFR 820.3(w) defines remanufacturer and is very specific. If you significantly changes the finished device's performance or safety specifications, or intended use then you are not a refurbisher.
 

sreenu927

Quite Involved in Discussions
#20
Re: Refurbished class 2 medical device which were returned because of 'Customer Remor

Hi I have a different opinion for the labeling.

3. Should we change labeling of refurbished device?
a. Should we change Serial Number? Yes, but it should have traceability to the original SN. May be one suggestion is to add "R" to the Serial Number to denote it as "refurbished" product.
b. Should we make a new labeling? Yes. The new label with new part number and revision should indicate that the product is refurbished in <Country> and refurbished date.
c. Can we use the same type of label, just to change e.g. Serial Number? Same type of label similar to your original label.
d. Should be there any note that unit is refurbished on the new label? Yes, see response to "b".

And you should update your batch records.

Regards,
Sreenu
 
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