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Service and maintenance in an initial importer facility USA

C

cerisette

#1
Dear all,

We are a company manufacturing medical devices based in France (manufacturing site) and we have an affiliate based in USA. This affiliate is the registered as an initial importer in USA.
We would like to know if trained people could perform the following activities in the initial importer facility:
- Service and maintenance of the cleared products
- Sell the refurbished products

I looked at the US regulation and I do not find any guidance about this. I would like to know what are the steps to follow in order to perform the aforementioned activities in an initial importer facility in compliance with FDA requirements:
- Is there any specific FDA requirements/ guidance related to this subject?
- Do we need to inform FDA about these activities?

I will really appreciate your feedback on this subject.
Thank you in advance.
 
M

MIREGMGR

#2
A service/maintenance/refurbishment facility is a Remanufacturer if the devices it works on have sub-standard performance and its work causes their performance to be brought back to a safe and effective level.

Remanufacturer - Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.​
See http://www.fda.gov/MedicalDevices/D...rationandListing/ucm053165.htm#remanufacturer.

If this applies to you, you must Register and List.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
Dear all,

We are a company manufacturing medical devices based in France (manufacturing site) and we have an affiliate based in USA. This affiliate is the registered as an initial importer in USA.
We would like to know if trained people could perform the following activities in the initial importer facility:
- Service and maintenance of the cleared products
- Sell the refurbished products

I looked at the US regulation and I do not find any guidance about this. I would like to know what are the steps to follow in order to perform the aforementioned activities in an initial importer facility in compliance with FDA requirements:
- Is there any specific FDA requirements/ guidance related to this subject?
- Do we need to inform FDA about these activities?

I will really appreciate your feedback on this subject.
Thank you in advance.
Hello and welcome to the Cove :bigwave:

The information you provided is not enough for a definite answer. "Service", "Maintenance" and "Refurbishment" could each mean lots of different things. Please try to explain in more detail what's going to be done and what sort of devices / equipment we are discussing.

Cheers,
Ronen.
 
C

cerisette

#4
Hi Ronen E and MIREGMGR,

First I would like to thank you for your feedback and my apologize for the late response but it seems I had there were a trouble because my my reply was not submitted.

Here are some additional details about our situation:
Our company is manufacturing imaging systems composed of central unit, computer screen?
1. These parts may be subjected to reparation or maintenance. In that case, we would like to train people working in our affiliate based in USA so they can be able to perform these kind of activities in the affiliate facility instead of bringing back the product to France.
All the quality data will be archived and managed in the manufacturing site (France) which is ISO 13485 certified.

2. We also would like to refubrish our products in the affiliate site. People in charge of this activity will be trained. The data will also be managed by the manufacturing site.

Would that be acceptable with "initial importer status"?
Thanks a lot for your help.
 
M

MIREGMGR

#5
My conclusion is that my previous response applies...your situation would be that of a Remanufacturer.
 
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