Anon,
The intent of the Swiss Authorised Representative and Importer information is similar to the EU MDR requirements. The Swiss Authorised Representative - CH-REP - information needs to be located on the device labelling whereas the Importer information can be on accompanying documents. There are a few others from Switzerland who could comment, but my understanding of expectations regarding this is CH-REP information is on the device labelling and the Importer information could be located somewhere else. Practically from the information needed, the CH-REP needs to be on the device to understand the local responsible and the Importer information needs to be known at importation.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 23-Jun-2023 15:41
From: Anne LeBlanc
Subject: Swiss Exit Labelling requirement
Hello AL
You'll find the English version of Swissmedic's information sheet here: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/pflichten-bevollmaechtigte.html
They are more flexible about the importer information than the CH REP information
------------------------------
Anne LeBlanc
United States
Original Message:
Sent: 23-Jun-2023 13:02
From: Nag Goutham Channagiri
Subject: Swiss Exit Labelling requirement
Hi,
To address your question, the information regarding the Swiss Representative and Importer typically needs to be included on the label of the product. Placing this information on the outer box of the product alone may not meet the requirement. The information should be included in each packaging level, including the primary packaging (the packaging directly in contact with the product), secondary packaging (outer packaging), and any other relevant packaging levels.
Additionally, the Swiss Representative and Importer information may also need to be included in the Instructions for Use (IFU) document accompanying the device. The IFU should provide clear instructions for the proper use of the device and any additional information required by the regulations.
Hope this helps.
Thanks,
------------------------------
Nag Goutham Channagiri
Regulatory Affairs Specialist
Wellesley MA
United States
Original Message:
Sent: 22-Jun-2023 13:10
From: Anonymous Member
Subject: Swiss Exit Labelling requirement
This message was posted by a user wishing to remain anonymous
Hello Everyone,
I wanted input on IVDo Swiss-Exit labelling requirement. Based on my understanding a lot of requirements in the IvDo are from IVDR regulation which also includes labelling. My question is as follows:
The Swiss Rep and Importer information currently can be provided on a separate document accompanying the device till 2025, post 2025 this information should appear on label. Does this mean documenting the CH-REP and CH-IMP on the outer box of the product meet the requirement?
OR
The information needs to be included in each packaging level (primary, secondary, etc) and IFU?
Looking forward for advice and discussion.
Best,
AL