Distribution of Medical Devices in US

ISO 13485 - Medical

Involved In Discussions
#1
If a European company is looking to set up a US company (INC), the headquarters in Europe but an office in the US only for distribution of their product is there any guidelines that are required to be followed if the US part of the company is only being used for sales and distribution ( and some marketing).

Do they need to register the company is the US with the FDA?


Do they have to adhere to part 820?

Thanks in advance
 
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M

MIREGMGR

#2
The Manufacturer of a device to be marketed in the US must have registered as an Establishment with the FDA. That's the HQ location, not the US office. That's done online. There's a fee per calendar year, payable starting in October.

They also must List their products, just as any other Manufacturer must. That's also done online. This requires that the Manufacturer know the products' FDA class and product code. If any of the products are Class II or III, regulatory clearances/approvals must be in place already. For a Class II product, that's normally a 510(k). For a Class III product, that's normally a PMA.

Every Establishment located outside the US must have a US Agent, who serves as the official point of contact if for some reason the FDA is not able to reach the foreign HQ location in a timely manner. Agents basically do nothing 99.9% of the time. If the Manufacturer does not have a US office, the Agent normally is either arranged via a contract relationship, or is the US initial importer/master distributor. If the Manufacturer has a US office, that office should be listed as the Agent.

All FDA Manufacturers must conform to 21 CFR 820 and all other applicable US regulations, no matter where they are located. Manufacturing must be conformant to the GMPs. If one or more contract manufacturers are used, those manufacturers must be effectively controlled and must operate in conformance with the GMPs. Labeling must comply with FDA regulations, which are significantly different from MDD requirements. The FDA may inspect foreign manufacturers. In theory this can be done with no advance notice.

In most cases, a well-run MDD/13485-conformant design and manufacturing control system, plus product documentation in the form of a change controlled Tech File or Design Dossier, plus retention of all design and manufacturing records, will be adequate as the required QS plus DMR, DHF and DHR.

In most cases, a well-run MDD-13485-conformant adverse event reporting system will be easily adapted to meet FDA requirements, which are conceptually similar but which differ in a number of details and requirements.
 

ISO 13485 - Medical

Involved In Discussions
#3
The Manufacturer of a device to be marketed in the US must have registered as an Establishment with the FDA. That's the HQ location, not the US office. That's done online. There's a fee per calendar year, payable starting in October.

They also must List their products, just as any other Manufacturer must. That's also done online. This requires that the Manufacturer know the products' FDA class and product code. If any of the products are Class II or III, regulatory clearances/approvals must be in place already. For a Class II product, that's normally a 510(k). For a Class III product, that's normally a PMA.

Every Establishment located outside the US must have a US Agent, who serves as the official point of contact if for some reason the FDA is not able to reach the foreign HQ location in a timely manner. Agents basically do nothing 99.9% of the time. If the Manufacturer does not have a US office, the Agent normally is either arranged via a contract relationship, or is the US initial importer/master distributor. If the Manufacturer has a US office, that office should be listed as the Agent.

All FDA Manufacturers must conform to 21 CFR 820 and all other applicable US regulations, no matter where they are located. Manufacturing must be conformant to the GMPs. If one or more contract manufacturers are used, those manufacturers must be effectively controlled and must operate in conformance with the GMPs. Labeling must comply with FDA regulations, which are significantly different from MDD requirements. The FDA may inspect foreign manufacturers. In theory this can be done with no advance notice.

In most cases, a well-run MDD/13485-conformant design and manufacturing control system, plus product documentation in the form of a change controlled Tech File or Design Dossier, plus retention of all design and manufacturing records, will be adequate as the required QS plus DMR, DHF and DHR.

In most cases, a well-run MDD-13485-conformant adverse event reporting system will be easily adapted to meet FDA requirements, which are conceptually similar but which differ in a number of details and requirements.
Thanks for the information and to follow up with another question:

If the UK company holds all the 510k Approvals and is already registered in the US with the FDA, what is required if they set up a US company (Company INC) for just distribution (including sales and marketing)?

Do they need to register the US Company with the FDA if the UK Company is already registered?

Do the US company need to be complaint with the QSR?
 
M

MIREGMGR

#4
If the UK company holds all the 510k Approvals and is already registered in the US with the FDA, what is required if they set up a US company (Company INC) for just distribution (including sales and marketing)?

Do they need to register the US Company with the FDA if the UK Company is already registered?
I'm assuming that the US company will be legally independent, i.e. arm's length, even though perhaps with coordinated management and/or shared ownership.

If the UK company remains the Manufacturer, then the US company will function as a distributor. Distributors are not required to register. Assuming that the products are labeled per FDA rules, this will be true even if the product labels identify the product as belonging to the distributor company, and do not mention the Manufacturer.

If on the other hand the UK company acts as a contract manufacturer and the US company has responsibility for the product...which I don't think is your intent, per your comments...then the US company would be the Manufacturer, and would have to register.

Do the US company need to be complaint with the QSR?
If the US company is a distributor, then no. Nor do they need to register as an Establishment and list their products.

However, note that in that case there must be both a contractural relationship and practical operational procedures between the US and UK companies to define responsibility for prompt adverse event information routing to the UK company so that they can conform to FDA requirements in that regard.

If the US company is the Manufacturer, then yes, and they must register as an Establishment and list their products.
 
H

hlg1102

#6
We are an initial distributor of a Class I device manufactured in the UK by Company XXX. So we have set up a US Company (the initial distributor) Company XXX, Inc. According to the FDA guideline, & we have registered our Inc. facility in the US, but we don't list. I am currently setting up a QMS for our US (Inc.) applicable to distribution/sales activities using 21 cfr 820. How much is actually applicable to these activities? I am currently setting up training files for sales, several purchasing SOPs, quoation controls, sales orders, receiving inspection SOPs, etc.. as I can see being overly cautious, but I can also see using few parts of 820 that apply. What are your thoughts??
 

ISO 13485 - Medical

Involved In Discussions
#7
I after setting up, the FDA have already been to audit.

They were looking at how we control training of staff, hospital staff etc and what records were kept and how we trained them.

The were also hot on boot stock and how this was controlled with regard to traceability, storage conditions ( i.e kept in a boot in Florida is different to be kept in a boot in the mid west).

You are not being over cautious all what you have mentioned they looked for at records that we were doing what we said.

We also put in a quality manual and then 6 SOP's on how we controlled the sales and marketing process, including training.
 
M

MIREGMGR

#8
We are an initial distributor of a Class I device manufactured in the UK by Company XXX. So we have set up a US Company (the initial distributor) Company XXX, Inc. According to the FDA guideline, & we have registered our Inc. facility in the US, but we don't list. I am currently setting up a QMS for our US (Inc.) applicable to distribution/sales activities using 21 cfr 820. How much is actually applicable to these activities? I am currently setting up training files for sales, several purchasing SOPs, quoation controls, sales orders, receiving inspection SOPs, etc.. as I can see being overly cautious, but I can also see using few parts of 820 that apply. What are your thoughts??
From the FDA's perspective, who is the Manufacturer? Has that company registered with the FDA as an Establishment, and listed the product? Are you the initial distributor, a practical role, or the Initial Importer, a specific FDA regulatory term?

US FDA and EC MDD classification rules are somewhat different, of course. When you say the product is Class I, are you referring to MDD Class I or FDA Class I?
 
H

hlg1102

#9
We are the Initial Distributor (Company XXX, Inc-new premises here in the US). We have already registered with the FDA as an establishment. The manufacturer is Company XXX in the UK. We are a class I-per FDA.
 
R

regork

#10
We are an initial distributor of a Class I device manufactured in the UK by Company XXX. So we have set up a US Company (the initial distributor) Company XXX, Inc. According to the FDA guideline, & we have registered our Inc. facility in the US, but we don't list. I am currently setting up a QMS for our US (Inc.) applicable to distribution/sales activities using 21 cfr 820. How much is actually applicable to these activities? I am currently setting up training files for sales, several purchasing SOPs, quoation controls, sales orders, receiving inspection SOPs, etc.. as I can see being overly cautious, but I can also see using few parts of 820 that apply. What are your thoughts??
As an initial importer, your QMS also needs to address 21 CFR 801, 803, 806, & 807.

much of 21 CFR 820 does not apply to an initial importer, however much of it is common sense and great to implement (record keeping, traceability, product ID, training, customer complaint handling). Be careful because if you hand over your QMS to an FDA inspector, s/he will read the whole thing and make sure you do it, even if it is not required!
 
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