What do we need for a DMR? Importer of Record and Going Crazy!

S

SuperGirl

#1
Hi, I am new to the Medical Device World and am the Quality and Regulatory Affairs Manager of the Small Medical Device Company. (I came from working in a QC Lab for a pharma company) We don't actually make any thing, but we are the importer of record of all of the products. Our Quality Consultant is very confussing and I'm kind of at a stand still. :bonk:The Consults say we need to have a device master record the list all of the spefication and references all the SOPs that go in to making the device as well as the testing, but when I attempt to get the infomation from our suppliers/contractos, they won't give up the information.

THE QUESTION: What do we need for a DMR?

Thanks! :thanx:
 
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M

MIREGMGR

#2
Re: Importer of Record and Going Crazy!

I assume that when you say you are the "importer of record", you mean two things:

1. You have been designated by the Manufacturer as their United States Agent.
2. You are the products' Initial Importer, and your company is FDA Registered in this role.

(See http://www.fda.gov/MedicalDevices/D...ce/ImportingandExportingDevices/ucm050126.htm.)

The Manufacturer of a medical device to be marketed within the US has full responsibility for that medical device's design and manufacture, whether the Manufacturer is located within the US or elsewhere. This includes having a 21CFR820 compliant quality system and maintaining a DMR and manufacturing records, among other things.

This responsibility cannot be offloaded to either the US Agent or the Initial Importer. Thus I don't understand why your consultant would suggest that your company, fulfilling those roles but not being the Manufacturer, would need to maintain a DMR.

You mention that there is some confusion between yourself and the consultant. Perhaps you need to sit down with them and attempt to get a clearer understanding of their advice in order to determine whether you've misunderstood it, or it is incorrect, or there are other elements of the situation beyond what is described here that change the nature of your role.
 
S

SuperGirl

#3
:thanx::applause: First of THANK YOU!


Yes, we are registered with the FDA and for some of the companies we act as thier US Agent as well. However, most of our contractors are independently registered with the FDA.
 
M

MIREGMGR

#4
OK, that introduces some confusion, at least for me. If your relationship with the actual manufacturer of a medical device is defined by both you and them as one in which they are a contract manufacturer, then your company is not an Initial Importer...it is the Manufacturer.

Which changes everything, and would explain why your consultant would want you to maintain a DMR, among other things.

Would you care to clarify?
 
S

SuperGirl

#5
This is were I get confussed as well. We bring in Medical Devices, mostly Class I, from Manufactures over seas, then we sell them to either distrubtors or end users. When I first started everyone called the Manufacturering Companies Suppliers. But our consultant told us to call them contractors.

Let me clarify our process of determining what products we are going to bring in. If someone has an idea for a product, we see what companies already make them, request sames from a few places, get price quotes, then decide which is best and order. We do not make any specifications. :frust: Becasue we don't make any specification, I believe these are suppliers and therefore we don't need a DMR, but the consultant say we need a DMR for each of our products.
 
M

MIREGMGR

#6
* Do the product labels identify the original maker as the Manufacturer? (or) Do they state your name accompanied by "Distributed By" or "Manufactured For"?

Are the original makers registered with the FDA as Manufacturers? Do they have 21CFR820-compliant quality systems?

Do the original makers perceive themselves to be the Manufacturer, per FDA regulatory definition, of the products that they sell to you to re-sell in the US?

Ideally, in order for you to be only a distributor of these products (whether or not you're the products' Initial Importer), all of these questions should be answerable with "yes", and you should have some sort of evidence to back up that answer.

* The fact that you do not explicitly create specifications is not determinative. Specification creation can be implicit, by means of purchasing an existing product for which the characteristics are known to you and identifiable by means of the product designator that you use to place the order.

* You mentioned that in some instances, a product maker has designated your company as their US Agent. Do you have that in writing?

If so, then you have clear evidence of being an Initial Importer for at least some of that company's products, and therefore a distributor.

* Of course, your situation may be something of a mish-mash, not clearly defined either way. If so, you should get it straightened out.

It's obvious that you want to be only a distributor. That cannot be the case unless the original makers agree that they are the Manufacturer. Every product marketed in the US must have a regulatorily responsible Manufacturer. If you import and resell that product, and the original maker doesn't agree that they're the Manufacturer, the FDA is likely to assume that you are the Manufacturer for purposes of your US sales.

In which case, you need those DMRs, among other things.

My suggestion (and I imagine your consultant's suggestion as well) would be that you not do business in this manner in the future without explicitly spelling out in your Purchase Order whether the company from which you are buying is expected by you to be a contract manufacturer, or the FDA responsible Manufacturer.
 
S

SuperGirl

#7
Thank you for all your wonderful help, and to everyone one here. Yes, we are only the Importer of Record/ Initial Importer for all of our devices. Everything is labeled "manufactured for".
 
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