Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello-
I am very new to Regulatory Affairs, and was thrown into the deep end- so to say- in regards to understanding the new Swiss MedDo requirements. I work for a mid- sized medical device company that has distribution agreements with other companies. That being said, several of our distributing partners would like to continue distributing our products in Switzerland, but are all outside of Switzerland. My understanding of the MedDo requirements is that an authorized representative (AR) is required to handle / approve such distribution requests. I am looking for guidance establishing AR. Is there a company that can be utilized to act as the AR? Does this position have to be seated in Switzerland? Any insight would be greatly appreciated!

Hi,

Please have a look at the enclosed guidance published by Swissmedic - https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html

I think you will find all the necessary answers.

Kind regards,

Itamar Urmann, RAC

------------------------------
Itamar Urmann
Lausanne
Switzerland
------------------------------

Original Message:
Sent: 05-Nov-2021 09:38
From: Anonymous Member
Subject: Switzerland MedDo and AR requirements

This message was posted by a user wishing to remain anonymous

Hello-
I am very new to Regulatory Affairs, and was thrown into the deep end- so to say- in regards to understanding the new Swiss MedDo requirements. I work for a mid- sized medical device company that has distribution agreements with other companies. That being said, several of our distributing partners would like to continue distributing our products in Switzerland, but are all outside of Switzerland. My understanding of the MedDo requirements is that an authorized representative (AR) is required to handle / approve such distribution requests. I am looking for guidance establishing AR. Is there a company that can be utilized to act as the AR? Does this position have to be seated in Switzerland? Any insight would be greatly appreciated!

This message was posted by a user wishing to remain anonymous

Itamar-
Thank you for the link, very useful information.
Original Message:
Sent: 06-Nov-2021 13:35
From: Itamar Urmann
Subject: Switzerland MedDo and AR requirements

Hi,

Please have a look at the enclosed guidance published by Swissmedic - https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html

I think you will find all the necessary answers.

Kind regards,

Itamar Urmann, RAC

------------------------------
Itamar Urmann
Lausanne
Switzerland

Original Message:
Sent: 05-Nov-2021 09:38
From: Anonymous Member
Subject: Switzerland MedDo and AR requirements

This message was posted by a user wishing to remain anonymous

Hello-
I am very new to Regulatory Affairs, and was thrown into the deep end- so to say- in regards to understanding the new Swiss MedDo requirements. I work for a mid- sized medical device company that has distribution agreements with other companies. That being said, several of our distributing partners would like to continue distributing our products in Switzerland, but are all outside of Switzerland. My understanding of the MedDo requirements is that an authorized representative (AR) is required to handle / approve such distribution requests. I am looking for guidance establishing AR. Is there a company that can be utilized to act as the AR? Does this position have to be seated in Switzerland? Any insight would be greatly appreciated!

MedEnvoy provides 3rd party Importer and AR services for EU/UK/CH.  I'm using them for a number of roles and can't speak highly enough about the service offering, process, and reasonable pricing.

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 05-Nov-2021 09:38
From: Anonymous Member
Subject: Switzerland MedDo and AR requirements

This message was posted by a user wishing to remain anonymous

Hello-
I am very new to Regulatory Affairs, and was thrown into the deep end- so to say- in regards to understanding the new Swiss MedDo requirements. I work for a mid- sized medical device company that has distribution agreements with other companies. That being said, several of our distributing partners would like to continue distributing our products in Switzerland, but are all outside of Switzerland. My understanding of the MedDo requirements is that an authorized representative (AR) is required to handle / approve such distribution requests. I am looking for guidance establishing AR. Is there a company that can be utilized to act as the AR? Does this position have to be seated in Switzerland? Any insight would be greatly appreciated!

This message was posted by a user wishing to remain anonymous

Thank you Tina!
Original Message:
Sent: 07-Nov-2021 13:16
From: Tina O'Brien
Subject: Switzerland MedDo and AR requirements

MedEnvoy provides 3rd party Importer and AR services for EU/UK/CH.  I'm using them for a number of roles and can't speak highly enough about the service offering, process, and reasonable pricing.

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand

Original Message:
Sent: 05-Nov-2021 09:38
From: Anonymous Member
Subject: Switzerland MedDo and AR requirements

This message was posted by a user wishing to remain anonymous

Hello-
I am very new to Regulatory Affairs, and was thrown into the deep end- so to say- in regards to understanding the new Swiss MedDo requirements. I work for a mid- sized medical device company that has distribution agreements with other companies. That being said, several of our distributing partners would like to continue distributing our products in Switzerland, but are all outside of Switzerland. My understanding of the MedDo requirements is that an authorized representative (AR) is required to handle / approve such distribution requests. I am looking for guidance establishing AR. Is there a company that can be utilized to act as the AR? Does this position have to be seated in Switzerland? Any insight would be greatly appreciated!