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Austria Medical Device EU Distributor Registration

M

MD_Simy86

#1
Dear all,
I'm looking for some information regarding notification to the Austrian Ministry of Health:

- the Distributor is inside the European Union, in Italy, and would like to sell CE-marked medical devices to end users, dentists and doctors in general, in Austria: I know that he must register to the Austrian Medical Device Registry but I don't know how and to whom require the log-in information;
is there anyone who can help me, please?
- I know that each European Distributor which would like to sell its medical devices in Austria should pay the Medical Device Fee annually;
is there anyone who can write me the prices and which is the link to the website in which find this information in English?

Thank you so much in advance for you support and I hope someone will answer me as soon as possible by this week!!

Bye bye,
Simona:bigwave:
 
Elsmar Forum Sponsor
#3
here you might get additional information:
medizinprodukteregister(dot)at - there is basic info in Englisch as well (menu-bar).

as far as I understand, there's no need for your company to register:
"In case a CE-marked product is already placed somewhere on the EU market and is already registered in the national registry of the corresponding country, it is not necessary to register the product again in the Austrian Medical Devices Registry."
 
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