Manufacturer - Distributor (Importer) Relationships

[Mark Meer]

I could use some clarification as to the specific responsibilities of (foreign) Manufacturers and local distributors (importers). Specifically with respect to MDR (21 CFR 803) and complaint handling (21 CFR 820.198).

A couple initial questions to help me better understand:

First:
Can the distributor (importer) take on all these responsibilities? If they wanted to, can they register as "Manufacturer", and then assume these responsibilities, even though technically, all they do is import and distribute. My gut says no, but this arrangement is being entertained here...

Second:
The MDR regulations consistently use the language "If you are a manufacturer or importer..." (emph. added). This does not make clear who is responsible. How are the responsibilities established? Through private contract agreements, or is there some mechanism to establish responsibilities through the FDA?

Any input/clarification, or links to relevant guidances would be much appreciated!
Thanks in advance!
MM.

 

[GStough]

I could use some clarification as to the specific responsibilities of (foreign) Manufacturers and local distributors (importers). Specifically with respect to MDR (21 CFR 803) and complaint handling (21 CFR 820.198).

A couple initial questions to help me better understand:

First:
Can the distributor (importer) take on all these responsibilities? If they wanted to, can they register as "Manufacturer", and then assume these responsibilities, even though technically, all they do is import and distribute. My gut says no, but this arrangement is being entertained here...

Second:
The MDR regulations consistently use the language "If you are a manufacturer or importer..." (emph. added). This does not make clear who is responsible. How are the responsibilities established? Through private contract agreements, or is there some mechanism to establish responsibilities through the FDA?

Any input/clarification, or links to relevant guidances would be much appreciated!
Thanks in advance!
MM.

Hi Mark,

From what I'm reading in these regs, the only ways your distributor can claim manufacturer status are: 1) They repackage or change the container, wrapper, or labeling of a device; or 2) They are the U.S. agent of a foreign manufacturer. Sounds pretty clear when you look at the definitions found in 21 CFR 803.3(e)(j)(l).

Perhaps others have a different interpretation and will share their thoughts.

Just curious, but why does your distributor (importer) want to take on these responsibilities?

 

[Mark Meer]

From what I'm reading in these regs, the only ways your distributor can claim manufacturer status are: 1) They repackage or change the container, wrapper, or labeling of a device; or 2) They are the U.S. agent of a foreign manufacturer. Sounds pretty clear when you look at the definitions found in 21 CFR 803.3(e)(j)(l).

That is my reading as well, also by the Definitions of Establishment Activities.

It appears that they could act in the capacity of parts 803 (reporting) and 806 (corrections and removals), as these regulations use the "...manufacturer or importer..." language I was inquiring about in the original post - still not sure how the responsibilities are formally established in practice, however. We've just, up until now, always assumed these responsibilities as the manufacturer.

Complaint-handling, however, is clearly the responsibility of the manufacturer, as per 820.198.

Perhaps others have a different interpretation and will share their thoughts.

Hope so... (nudge, nudge)

Just curious, but why does your distributor (importer) want to take on these responsibilities?

Not sure. Maybe they've just got a well integrated system, and standard agreement with all partner manufacturers? ...but if they want to alleviate responsibilities from us, I'm fine with that, as long as it's done by the book and we're complying with regulations. (hence my original post)