Why would you need a Swiss Authorised Representative and Importer?
Since May 26th, 2021 Switzerland is now considered a non-EU country for Medical Devices. So to sell your products in Switzerland you need a Swiss Authorized Representative and a Swiss Importer. In this episode of the podcast, I will explain to you the reason for all that and the role and responsibility for the Manufacturer who wanted to ship its products to Switzerland and one of the Swiss Importers and Authorised Representative. If you have any questions, reach out to me: info at easymedicaldevice.com
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses…
Links
- Swiss Meddo: https://www.fedlex.admin.ch/eli/cc/2020/552/en
- Swiss Economic Operators Guidance: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html
- Swiss CHRN Number: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/registriernummer-chrn.html
8 Replies to “Why would you need a Swiss Authorised Representative and Importer?”
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Thank you for this podcast!
Just a note about Requirements for manufacturer located outside EU – that is not 100 % correct – It should be “manufacturers established in an EU/EEA state or which have an authorised representative in an EU/EEA”
Good afternoon,
I am looking for an independant CH importer for a German distributor of medical devices. Can you provide this kind of service?
Regards,
Astrid Williame
Hi Astrid, sorry just saw your comment. Yes we provide that service. Go to https://easymedicaldevice.com/swiss-authorised-representative/
Hi Monir,
Thanks for this usefull video !
What is the date for a MD which is class I according the MDD but would be class II according the MDR ?
At the moment, they are not MDR compliant because they take advantage of the transitional period…
Thanks
Benoit
The date per EU MDR artice 120(3) is May 26 2024. But only if there was no significant changes during the transition.
Thanks for your answer Monir.
Even if this manufacturer markets his MD in Switzerland ?
How would we contact you to get more information how to we can pick Swiss rep.
Hi James,
You can send a message to swiss at easymedicaldevice.com we will then show you the process and define a quote for the service.