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Registration of other manufacturers devices

JoCam

Trusted Information Resource
#1
Hi All,

As a medical device manufacturer based in the UK, am I able to register medical devices manufactured at one of our subsidiaries based in Sweden outside of Europe, or does this need to be done by the Swedish manufacturing site?

JoCam
 
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twanmul

Involved In Discussions
#2
The UK site will need to, but it depends in what capacity based on who is the legal manufacturer (i.e. whose address is on the label).
If it's the UK site, then the UK manufacturer will need to register as the manufacturer.
If the legal manufacturer is the Swedish site, then the UK manufacturer will need to register (assuming they are willing to be) as the UK Responsible Person on behalf of the Swedish based manufacturer.

FYI - Sweden is in Europe.
 

JoCam

Trusted Information Resource
#3
The UK site will need to, but it depends in what capacity based on who is the legal manufacturer (i.e. whose address is on the label).
FYI - Sweden is in Europe.
Hi twanmul,

The label carries the Swedish site address as the manufacturer, which means that they will need to register. When we become the UK RP, we will be registering their devices in the UK, but will we also be able to register them in the US, Canada and Australia on their behalf?

Jo
 

twanmul

Involved In Discussions
#4
As far as I'm aware, a manufacturer based outside the UK cannot register a device with the MHRA and will need a UK Responsible Person to register their device on their behalf. This could be either the parent/subsidiary company or a third party but cannot be the legal manufacturer (where the legal manufacturer is not based in the UK).
Unfortunately I'm not that familiar with the requirements of those three markets, though I understand you will need a local in-market representative for registration and/or import purposes in each of them on top of MDSAP certification.
 
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