Brasil: OEM Medical Device Business - Product Design Customization

[3l5m4r]

Hi,

I've skimmed through the massive amount of forums / posts regarding medical device registration in Brasil but haven't found an answer to my following questions:

Our company is doing OEM business in the medical device sector. Hence, we're interested in customizing e.g. the design / trade name of a device for different distributors. Now: We're trying to figure out how much customization (design & name -- no technical features) can be done given that we do not want to obtain a new registration.

As far as I know, it should be possible, to obtain an INMETRO certificate for a product (one item number) with different trade names. There seems to be a new resolution on that from June 2016 (I have done some research but haven't found it yet -- could anyone help?).

However, I was told that this doesn't mean that we'd also get ANVISA approval for the device with different trade names. Can anyone share experiences or does anyone here know, whether there are (written) regulations on that?

Also: Is there any definition of the term "trade name"? Would the following be possible? Distributors A + B sell a device (using the same registration) with trade name "XYZ" on the device label. Distributor A gets a customized design which has the words "cool device" all over it and distributor B gets another customized design which has the words "awesome device" all over it. Or would those wordings be considered to be trade names (even though, they don't appear on the device label itself)?

I'm referring to class I devices. And by "design customization" I simply mean different prints on the device -- those customizations do not have any impact on safety and Performance or any other characteristics of the device (except its appearance).

I'd be really glad if someone has some answers to those questions.

 

[Marcelo]

I'm not sure I understand your questions. For example, what exactly do you mean by design customization?

Anyway, for the same device, you cannot have more than one trade name. You can only have more than one trade name on a registration if it's a device family, and in this case each device which is part of the family has to have its own trade name. This is the same for INMETRO (which is tied to the ANVISA registration).

AFAIK, there's no definition of "trade name" in medical device regulations. But it means the name the device put on the market is known by (sometimes it's also called "model" in some regulations). The idea is to exactly identify the device that is granted registration.

With this in mind, in your example, if you keep the trade name the same (well, if you keep the label the same) and put some words on different devices, if may not be a problem. However, it may induce an idea that the devices are different, which would be against the purpose of the trade name.

(Also, In your example, are the distributors registrations holders of each device registration? If not, who is the registration holder? Distributors sell the device, but they do not necessarily hold the registration.).

 

[3l5m4r]

Hi Marcelo,

Thanks for your instant and detailed reply - I highly appreciate it.

By "design customization" I mean different prints on the products -- i.e. a different 'product name', company logo, etc printed on the device. However, the devices would not differ in any way with regards to shape, size and the device label (i.e. identical trade names on the device labels). The only reason, I would want the official trade names on the device labels to be identical is so that both distributors could use the same license. License holder would be our local subsidiary (not a distributor).

I agree -- this could lead people to think that the devices are different (which they aren't). And I do agree that this would somehow be against the purpose of trade names.

However: How else would it be possible to sell the devices (with a different "look" for each distributor) to different distributors and still use the same registration? It doesn't seem to make sense to submit individual registrations for the same product only because the prints differ slightly. Also, selling the product with identical design to every individual distributor is not really an option.

If you have other suggestions on how to achieve that goal, I'd be more than glad, if you could share them...

P.S.: The information I received with regards to obtaining an INMETRO-certificate for one product with different trade names referred to the trade names as "commercial presentations". Does that make a difference?

 

[Marcelo]

However: How else would it be possible to sell the devices (with a different "look" for each distributor) to different distributors and still use the same registration?

I think this is the problem. Generally, a device has one registration holder, and this registration holder sells the device (the same device, including labeling) thru different distributors.

The way you want to do is, in practice, to have different devices (even if the design/functionality is the same). Changing the trade name the way you intend, it's another device. It needs another registration.

So, the answer the question above is, you can't. You would have to have different registrations to do what you want.

P.S.: The information I received with regards to obtaining an INMETRO-certificate for one product with different trade names referred to the trade names as "commercial presentations". Does that make a difference?

"Commercial presentation"is in fact a term ANVISA uses, not INMETRO. The concept you seem to mention is possible related to a system with different equipment that can be grouped in different ways.

 

[3l5m4r]

Marcelo- thanks again for your quick and detailed reply.

How about not having a brand / trade name printed on the product, but instead, have some generic name on it (which is different from the "type" on the type plate / device label)?

Let's say, I'd develop e.g. a new defibrillator and in the registration, I'd refer to it's type as "SAED-100". Of course, I'd then have to refer to it's type on the type plate / device Label as "SAED-100" as well. However: Would it be possible to print the word "defibrillator" (which I would say is pretty generic) somewhere on the housing? After all, this would probably not be confused with a trade name / brand.

 

[Access2hc]

hi - just reading with interest here.

the crux of the matter is if the 'commercial presentation' (btw, really cool way of describing this) has any pertinent information that may unknowingly mislead end-users to thinking that it is a different product. perhaps you'd like to consider a benefit vs. risk decision-making process to see how would that impact actual sales? if it's different design and colour and all that of course, it'll be harsh of any regulator (although it has happened before) to say that it's different devices when it's functionally the same, and as the same device label

hope it helps

Cheers,
Ee Bin
Access2hc

 

[3l5m4r]

So basically, since there seem to be no explicit regulations on that, it all comes down to the question of whether the responsible person at ANVISA would consider the print to be misleading or not -- I guess the only way to find out whether this works or not is by simply trying it...

I'm not quite sure yet what our company strategy will be regarding this issue, however, I'll make sure to let you all know if we make any experiences worth mentioning...