Where does our regulatory responsibility end?

#1
We have a good customer (let's call them ABC) that buys our medical device (software) and rebrands/relabels it for sale as a product with their name on it.

They now want to sell our medical device in Mexico. This would not be an ABC-rebranded or relabeled version of our medical device, but our very own medical device. We currently do not have market authorization to sell medical devices in Mexico. I do not know if ABC has the proper authorization either, but if I had to guess, I would say they do not. On the surface, ABC's proposal seems similar to distributor arrangements/agreements we have with other customers, but the difference is the other customers are not selling to Mexico, or any other places where we do not have market authorization. My questions are:
  • where is the registration-responsibility line drawn? In other words, once we sell our medical device to ABC, does our regulatory involvment end at that point and what they do with their purchase is their business?
  • is the onus on ABC or us to get the proper medical device registration and approval for Mexico?
  • knowing that ABC intends to sell to Mexico after we sell to them, should we even entertain the thought of selling our medical device to them in the first place?

Can anybody out there offer any insight?
 
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Mark Meer

Trusted Information Resource
#2
  • where is the registration-responsibility line drawn? In other words, once we sell our medical device to ABC, does our regulatory involvment end at that point and what they do with their purchase is their business?
  • is the onus on ABC or us to get the proper medical device registration and approval for Mexico?
  • knowing that ABC intends to sell to Mexico after we sell to them, should we even entertain the thought of selling our medical device to them in the first place?
Hi markg123, welcome to the Cove! :bigwave:

I'm no expert in this sort of arrangement, but I'll offer my 2 cents:

First, do you have a distribution agreement with them? If so, what does it say? If they are breaching contract by reselling devices to other areas without your permission, then certainly you would want to reevaluate your relationship with them!

Like many countries, Mexico requires an in-country representative to go through the regulatory process. If your distributor already has such a representative (and is maybe even willing to pay any regulatory costs), then the distributor can go through the registration on your behalf. You would want to ammend any agreements to spellout these responsibilities explicitly. Ultimately, however, you as the manufacturer are responsible...so whether you do it yourself, or entrust 'ABC' to do it for you is up to you.

I've also wondered about the registration-responsibility line. If I sell to a private end-user, and they later sell the device on ebay to a person in another country, do I bear any legal liabilities? I think, in the realm of distributors, it would come down to the agreements/contracts, and your knowledge. If they, unbeknowst to you, are violating an established agreement by re-selling your devices willy-nilly, then they should be accountable. If, on the otherhand, you are aware of this practice, but tacitly approve it by not stopping it, you would be liable.

Like I say, this is all my opinion. Not sure how it plays out in practice.
Curious to know what others think...

MM
 
A

Access2hc

#3
If they become your distributor, then the requirements for a distributor agreement applies.

the first step is to ensure ABC does have market authorisation to market medical devices in Mexico - regardless if it is your device or the branded ABC device, then as part of the distributor agreement, either party can take care of the product registration.

when that is settled, then ensure the same process is applied if ABC wishes to market your device to other countries.

Hope it helps

Cheers,
Ee Bin
Access2hc
 
#4
Does anyone else have something to offer here? I have the exact same question and was hoping to have a more definitive answer.

Thanks in advance,

Paul.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#5
Ee Bin is correct here. I suspect that ABC doesn't have legal authority to sell their own-branded version so they are opting to sell the OEM's version maybe hoping that the OEM is already registered there. One or the other will need to enter the registration process.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#6
Does anyone else have something to offer here? I have the exact same question and was hoping to have a more definitive answer.

Thanks in advance,

Paul.

Hi. I work for a company that sells a single use device in the retails space. We have resellers that can sell it in the USA or EU or Australia. If they tried to sell it anywhere else it would be a violation of our agreement.

On the other hand there were instances of individuals buying them en masse on Amazon and selling them via Ebay in other countries. In that case the individual is breaking the law and not us.

If you have trouble trusting your own distributor I think you have a bigger problem here.
 

Mark Meer

Trusted Information Resource
#7
On the other hand there were instances of individuals buying them en masse on Amazon and selling them via Ebay in other countries. In that case the individual is breaking the law and not us.
I'm curious what the manufacturer's responsibility is in such cases, once they are made aware. For example, if you realise someone is engaging in this (say, a device-user - who you've never interacted with - contacts you with a complaint), what is your responsibility? What avenues, if any, do you pursue? Legal? Criminal?
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#8
When you discover that your device is being sold in places that it shouldn't, you are obligated as the legal manufacturer to address the matter. How is contingent on the issue itself especially with regard the genesis of the issue and discovery (did you learn from a consumer? a customer? a regulatory body?). In the case above, normally a controlled market withdrawal by the entity who sold the devices is in order. The legal manufacturer should oversee this action and as necessary, work with the regulatory body (e.g., explain the situation and the steps being taken). Different tactics would be in order if you received a unit for service from an entity that you hadn't sold it to from a country you don't sell in.
 
K

Kathy Moon

#9
On a different matter regarding Mexico... I am trying to understand labeling requirements for medical devices that are to be imported for non-commercial use. We have an importer that has provided us with an import permission certificate and it states a small quantity of devices that would be used in what they describe as a laboratory. The tests they want to do are on the device itself --- length, weight, analysis of packaging... I've researched the law in Mexico regarding labeling and the only mention of laboratory testing has to do with in vitro laboratory testing. I think that the importer is just using the "laboratory testing" justification to get around Sanitary registration requirements. However, if it is legitimate, I cannot find whether or not we need to put the word "SAMPLE" or "not for human use" on our labeling --- and if it needs to be in Spanish. Can anyone offer me insight here?
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#10
When you discover that your device is being sold in places that it shouldn't, you are obligated as the legal manufacturer to address the matter. How is contingent on the issue itself especially with regard the genesis of the issue and discovery (did you learn from a consumer? a customer? a regulatory body?). In the case above, normally a controlled market withdrawal by the entity who sold the devices is in order. The legal manufacturer should oversee this action and as necessary, work with the regulatory body (e.g., explain the situation and the steps being taken). Different tactics would be in order if you received a unit for service from an entity that you hadn't sold it to from a country you don't sell in.
Well, we found devices being sold illegally in China. We contacted the SFDA in China and other regulators. 5 years later it is still occurring. This all depends on the market my friend :)
 
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