Selling our own class 1 (EU) devices worldwide - Who is responsible for registration?

[Anoniem]

Hi,

We are a small company in the EU selling our own class 1 (EU) devices worldwide. We help distributors with information they need for their local registration. But some distributors just sell, without asking us for any regulatory documents. Should we exactly know all regulations in all export countries? Or is our distributor (the local importer) responsible for that?

Another similar question, we buy a Class 2b CE marked device from the USA. We would like to sell this device in Asia. We are not the manufacturer. Who is responsible for registration? The USA manufacturer, we because we ship it to Asia, or the local importer?

Thank you very much for your help!

 

[Stijloor]

Re: Selling our own class 1 (EU) devices worldwide - Who is responsible for registrat

A Quick Bump!

Can someone help?

Thank you very much!

 

[Marcelo]

Re: Selling our own class 1 (EU) devices worldwide - Who is responsible for registrat

Generally, as the manufacturer, you are responsible to know and apply all regulatory requirements. Usually you need to have a "registration holder" or "authorized representative" or something like that in each country, which will perform the registration process in your behalf.

 

[somashekar]

Re: Selling our own class 1 (EU) devices worldwide - Who is responsible for registrat

Hi,

We are a small company in the EU selling our own class 1 (EU) devices worldwide. We help distributors with information they need for their local registration. But some distributors just sell, without asking us for any regulatory documents. Should we exactly know all regulations in all export countries? Or is our distributor (the local importer) responsible for that?

Another similar question, we buy a Class 2b CE marked device from the USA. We would like to sell this device in Asia. We are not the manufacturer. Who is responsible for registration? The USA manufacturer, we because we ship it to Asia, or the local importer?

Thank you very much for your help!

Unless a specific country/s is mentioned, it is not possible to address your question. Your local importer does have some regulatory responsibility, but their ignorance can prove costly to you. You need to know and perform specific stuff for sure, as your name is on the device label.
For the second question, again country name information is essential. You may still have some responsibility in the regulatory chain.

 

[Anoniem]

Re: Selling our own class 1 (EU) devices worldwide - Who is responsible for registrat

Thank you for your answers. For us it is just a general understanding of the responsibilities.

Our own class 1 devices will be sold in many countries, as lots of companies are willing to sell them locally. Companies in countries like India, Iran, Russia, Japan, Colombia, South-Korea etc. We support these distributors with what information they ask for, but for a small manufacturer it is impossible to be familiair with all worldwide regulations and requirements.

The country about which I placed the second question is South-Korea.
Thank you again for your help!

 

[somashekar]

Re: Selling our own class 1 (EU) devices worldwide - Who is responsible for registrat

Hi ...
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Note: I am not associated with them in any way.

 

[Ronen E]

Re: Selling our own class 1 (EU) devices worldwide - Who is responsible for registrat

for a small manufacturer it is impossible to be familiair with all worldwide regulations and requirements.

Impossible? Not sure. Resource intensive, maybe. Either way, regulations are a fact of life that you can't avoid. Not knowing represents a risk. How you address (or not) that risk is up to you. Once you decide to sell to someone, you have made a choice and have a responsibility for that choice. You could choose to refrain from finding out what exactly are your legal obligations associated with that choice, it's just a matter of choosing to operate under a different risk level (whether you have defined that risk or not).

 

[Ronen E]

Re: Selling our own class 1 (EU) devices worldwide - Who is responsible for registrat

Generally, as the manufacturer, you are responsible to know and apply all regulatory requirements. Usually you need to have a "registration holder" or "authorized representative" or something like that in each country, which will perform the registration process in your behalf.

In some countries this isn't exactly the situation. In Australia for instance, the primary legal responsibility lies with the Australian Sponsor (the "registration holder"), which is different from the manufacturer for off-shore manufacturers. The manufacturer has regulatory obligations but for the lower classes devices they are mostly applied indirectly, through the Sponsor. If something regarding the device is not in compliance in Australia, the authorities will hold the Sponsor initially responsible. BTW, if a device is not included on the ARTG ("registered" in Australia) it's unlikely to pass border control.

Cheers,
Ronen.