Good day Melanie,
As far as I know there is no specific medical device or IVD requirements in Tunisia - the only link I have is to the Ministry of Health:
http://www.dpm.tn/. Most of their regulations are around pharmaceutical products. Though with that said, maybe there is something in the current regulations - when I was working on this many years ago, they basically recognised CE Marking and accepting the CE Certificate as part of importation.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Jun-2020 05:50
From: Melanie Martini
Subject: Tunisia
Hello everybody,
I am looking for any registration information or guideline of CE-marked IVDs in Tunisia.
What do I ahave to do as Legal Manufacturer to sell my products to this country?
Thanks a lot for any links.
Best.
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Melanie Martini
Berlin
Germany
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