Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi Everyone, 
My apologies if this question was asked before. 

We are a medical device manufacturer located in Canada and I am still not fully convinced that we need a local UK importer.
We have a potential deal with a UK customer, and I wonder if we can send our devices ( a couple of hundreds) directly to that customer. 
I would appreciate it if anyone can explain the requirement and process to me. 

Thank you

Hi Anon

Per the MHRA website info, the basic rule is if your products are registered, you can sell them there. If your customer wants to import them into the UK directly from you, they just have to notify your UKRP.

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk


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Anne LeBlanc
United States
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Original Message:
Sent: 01-Feb-2022 20:17
From: Anonymous Member
Subject: UK Importer - Do we need one ?

This message was posted by a user wishing to remain anonymous

Hi Everyone,
My apologies if this question was asked before.

We are a medical device manufacturer located in Canada and I am still not fully convinced that we need a local UK importer.
We have a potential deal with a UK customer, and I wonder if we can send our devices ( a couple of hundreds) directly to that customer.
I would appreciate it if anyone can explain the requirement and process to me.

Thank you