Good Distribution Practices - Medical devices

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Q

QSMLauren

#2
Thanks for posting this link. It looks like a great guideline. I need help trying to define requirements for U.S. and International distributors of Medical Devices. We are a manufacturer, the sells via distributors, and I am trying to gather all of the requirements our channel needs to adhere to.

What I can tell so far is:

U.S.
1. Keep Complaint files and make them readily available for the FDA, but they do not have to report adverse events. (21 CFR 803)
2. Distributors do not need to register their facility or list products. (807.20 c3)

Question #1: Is there anything else a Distributor of a Medical Device is required to do in the U.S?

Int'l -
Question #2: Is there any known country regulation that details requirements for Distributors of Medical Device Product?

Thanks helping. New to site and already finding great stuff.

Lauren
 

Marcelo

Inactive Registered Visitor
#3
Hello Lauren and welcome to the Cove.

This is just a general comment on your question.

Distributors (initial distributors) are generally regarded as manufacturers by the regulatory requirements, so the same requuirements that manufacturrs have, with some modification and interpretations, are applied to distributors. This means that, for example, a quality system regulation might be applied to distributors.

In Brazil, although not enforced, it´s expected that distributors adhere to Good Manufacturing (Distributor) practices according to RDC 59, the same regulation applied to manufacturers. If you take a look at 21 CFR 820, you will see that it applies to initial distributors also.

Regarding secondary distributors, this is not so clear, but it´s generally expected that they have similar requirements.
 
Q

QSMLauren

#4
Thanks for the info. Per this definition from FDA code:

Initial Distributor - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address

I believe our U.S. distributors are secondary distributors; as we are in the U.S. so they are not imported here.

My current thinking is :Yes, it is good to comply with GMP requirements as they relate to any company that distributes medical devices, but from what I can tell; it is not "required per any FDA rule".

Lauren
 

Marcelo

Inactive Registered Visitor
#5
Thanks for the info. Per this definition from FDA code:

Initial Distributor - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address

I believe our U.S. distributors are secondary distributors; as we are in the U.S. so they are not imported here.

My current thinking is :Yes, it is good to comply with GMP requirements as they relate to any company that distributes medical devices, but from what I can tell; it is not "required per any FDA rule".

Lauren
This is because you, as the manufacturer, has to control your distributors, the same as you control your supplers for example. These requirements you mentioned will be your requirements, not requirements directly from the FDA. So no, i don´t think there will ever be FDA requirements for secondary distributors, unless FDA starts to also have requirements for medical device manufacturer suppliers.
 
M

MIREGMGR

#6
I need help trying to define requirements for U.S. and International distributors of Medical Devices. We are a manufacturer, the sells via distributors, and I am trying to gather all of the requirements our channel needs to adhere to.

What I can tell so far is:

U.S.
1. Keep Complaint files and make them readily available for the FDA, but they do not have to report adverse events. (21 CFR 803)
2. Distributors do not need to register their facility or list products. (807.20 c3)
#1 in your list may be a literal reading of 21CFR 803, but it's not a functional stance. Adverse events must be reported by someone. If the information reaches the distributor first, the distributor should make very sure it's passed on to the responsible Manufacturer to be reported to the FDA within the legal time window. Letting an adverse event go unreported because it's not your job to report it, is neither a good idea nor assuredly acceptable from a legal perspective. The FDA has been known to hold co-responsible other involved parties besides the Manufacturer, in circumstances where an implied duty-to-maintain-patient-safety is willfully or negligently ignored.

MMAntunes said:
Distributors (initial distributors) are generally regarded as manufacturers by the regulatory requirements, so the same requuirements that manufacturrs have, with some modification and interpretations, are applied to distributors. This means that, for example, a quality system regulation might be applied to distributors.
This statement may be misleading. An "Initial Distributor" is the highest-level element of the US distribution chain for a device that is Manufactured outside of the US, and imported into the US. A US Manufacturer, such as QSMLauren, won't have an Initial Distributor.

Is there any known country regulation that details requirements for Distributors of Medical Device Product?
Many countries have rules for distributors...perhaps more than have rules for manufacturers...certainly too many to list.
 

Marcelo

Inactive Registered Visitor
#7
Quote:
Originally Posted by MMAntunes

Distributors (initial distributors) are generally regarded as manufacturers by the regulatory requirements, so the same requuirements that manufacturrs have, with some modification and interpretations, are applied to distributors. This means that, for example, a quality system regulation might be applied to distributors.
This statement may be misleading. An "Initial Distributor" is the highest-level element of the US distribution chain for a device that is Manufactured outside of the US, and imported into the US. A US Manufacturer, such as the OP, won't have an Initial Distributor.
Sorry MIREGMGR, didn´t understand your comment. You are right, a US manufacturer won´t have a initial distributor, that´s why the regulations will be applied directly to them....they are the manufacturer, when in the case of a imported device, the initial distributor will be seen as the manufacturer.
 
Q

QSMLauren

#8
Thanks - appreciate the comments. Can now go forward to make sure we are communicating our expectations our distributors. (For example, Yes, we DO want to know about any adverse events...the distributor just needs to report them to us, not the FDA directly); etc.

Lauren
 
Q

qamama

#9
Good morning... I hope all is well on the forum this great day :D

I would like to know where the definition of the "initial distributor" comes from? And which regulation states they are under the same regs as manufacturers?

I appreciate any who can let me know which doc says this :D

Thank you
 

Ajit Basrur

Staff member
Admin
#10
Good morning... I hope all is well on the forum this great day :D

I would like to know where the definition of the "initial distributor" comes from? And which regulation states they are under the same regs as manufacturers?

I appreciate any who can let me know which doc says this :D

Thank you
From FDA,

Initial Distributor - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.
 
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