C
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.
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.
