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

[v9991]

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.

 

[Ronen E]

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

Who is the legal manufacturer?

 

[ssz102]

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

 

[v9991]

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

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.

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.

 

[Ronen E]

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

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.)?

 

[v9991]

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

"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.

 

[Ronen E]

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

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?

 

[v9991]

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.

 

[Ronen E]

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.

OK, thanks for clarifying that.

Look, I won't pretend to be a top expert on India's medical devices regulatory system. However, you referred to "...facilities compliant with the FDA regulations on invitro pregnancy diagnostic kits..." and hence the linkage to USA regulation. If the system in India has a clearance route that relies on compliance with specific USA provisions, this may be of relevance; otherwise the USA's is just another system, and you could just the same relate to the MDD, ISO 13485 or any other relevant benchmark.

If you do intend to rely on the USA system, it in fact places significance on who is the legal manufacturer; much so that sometimes no direct regulatory requirements are placed on the actual maker of the device. If no particular significance is placed on the USA system, then I'd say just follow Good Sourcing Practices (supplier evaluation and qualification etc.).

I hope it helps to an extent. Does it?

 

[v9991]

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

OK, thanks for clarifying that.

Look, I won't pretend to be a top expert on India's medical devices regulatory system. However, you referred to "...facilities compliant with the FDA regulations on invitro pregnancy diagnostic kits..." and hence the linkage to USA regulation. If the system in India has a clearance route that relies on compliance with specific USA provisions, this may be of relevance; otherwise the USA's is just another system, and you could just the same relate to the MDD, ISO 13485 or any other relevant benchmark.

If you do intend to rely on the USA system, it in fact places significance on who is the legal manufacturer; much so that sometimes no direct regulatory requirements are placed on the actual maker of the device. If no particular significance is placed on the USA system, then I'd say just follow Good Sourcing Practices (supplier evaluation and qualification etc.).

I hope it helps to an extent. Does it?

exactly, i think i must have brought about same level of details you have mentioned; and my question starts right there. Supplier QMS would anyways&always be there; My query was about the product evaluation; would it follow complete assessment; how would you compare the products sourced between two manufacturing units....etc.,