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Product Evaluation Requirements for Change in Manufacturing Facility/Change in Design
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Product Evaluation Requirements for Change in Manufacturing Facility/Change in Design
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Product Evaluation Requirements for Change in Manufacturing Facility/Change in Design

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  Post Number #1  
Old 13th June 2012, 10:19 PM
v9991

 
 
Total Posts: 957
Please Help! Product Evaluation Requirements for Change in Manufacturing Facility/Change in Design

we are inlicensing the product,
what are the evaluation criteria we must follow in following conditions.
1) before allowing the change in manufacturing site. (same design of device)
2) sourcing product different partner; (consider that product from both facilities are compliant with the FDA regulations on invitro pregnancy diagnostic kits...)

thank you for your insights.

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  Post Number #2  
Old 13th June 2012, 11:13 PM
Ronen E

 
 
Total Posts: 3,736
Re: Product Evaluation Requirements for Change in Manufacturing Facility/Change in De

Who is the legal manufacturer?
  Post Number #3  
Old 13th June 2012, 11:35 PM
ssz102

 
 
Total Posts: 368
Re: Product Evaluation Requirements for Change in Manufacturing Facility/Change in De

i don't know what is product does your company produce?

if it is automobile industry, you can implement according with VDA 6.3
  Post Number #4  
Old 14th June 2012, 12:18 AM
v9991

 
 
Total Posts: 957
Re: Product Evaluation Requirements for Change in Manufacturing Facility/Change in De

Quote:
Who is the legal manufacturer?
Both the manufacturers are authorized/approved by FDA.
so we intend to shift the sourcing of device from 1 to another.

Quote:
i don't know what is product does your company produce?
if it is automobile industry, you can implement according with VDA 6.3
although we are into medical device market... can you pl. outline the requirements specified in VDA 6.3.

thank you.
  Post Number #5  
Old 14th June 2012, 12:46 AM
Ronen E

 
 
Total Posts: 3,736
Re: Product Evaluation Requirements for Change in Manufacturing Facility/Change in De

Quote:
In Reply to Parent Post by v9991 View Post

Both the manufacturers are authorized/approved by FDA.
so we intend to shift the sourcing of device from 1 to another.
"Legal Manufacturer" means the entity under which name the product is placed on the market. Typically it would be the most prominent name (+contact details) on the device's labeling, unless a contract-manufacturing arrangement is in place and the contract (or other legal agreement) states that the actual manufacturer is regulatorily responsible.

So, I was actually asking who is the primary regulatory responsible party; not who is actually fabricating the device. Is it your company or another entity (e.g. licensee etc.)?
  Post Number #6  
Old 14th June 2012, 12:56 AM
v9991

 
 
Total Posts: 957
Re: Product Evaluation Requirements for Change in Manufacturing Facility/Change in De

Quote:
In Reply to Parent Post by Ronen E View Post

"Legal Manufacturer" means the entity under which name the product is placed on the market. Typically it would be the most prominent name (+contact details) on the device's labeling, unless a contract-manufacturing arrangement is in place and the contract (or other legal agreement) states that the actual manufacturer is regulatorily responsible.

So, I was actually asking who is the primary regulatory responsible party; not who is actually fabricating the device. Is it your company or another entity (e.g. licensee etc.)?
we do the import registration; and we would be point of contact for the patient and as well as regulator.
  Post Number #7  
Old 14th June 2012, 12:59 AM
Ronen E

 
 
Total Posts: 3,736
Re: Product Evaluation Requirements for Change in Manufacturing Facility/Change in De

Quote:
In Reply to Parent Post by v9991 View Post

we do the import registration; and we would be point of contact for the patient and as well as regulator.
I see that your location is indicated as "India". Are you relating to importation into India or into the USA?
  Post Number #8  
Old 14th June 2012, 01:09 AM
v9991

 
 
Total Posts: 957
Re: Product Evaluation Requirements for Change in Manufacturing Facility/Change in De

Your observation is right, we get the product into india.
but regulatory expectations would be as strong as they are enforced; hence the query is more on quality side of it.
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