Portugal Class I Medical Device Registration of device made in Italy

MD_Simy86

Inactive Registered Visitor
#1
Dear all,
I'm looking for a clarification regarding class I medical devices.

The Manufacturer is Italian and would like to sell its class I medical device in Portugal.
I know that he doesn't have to notify it to INFARMED but I'm asking you if the registration in the Italian databank is enough or is it necessary anything else, in order to put the product in the Portoguese market.

Thank you in advance for the help!

See you:bigwave:
 
#2
I don't believe the manufacturer has to notify anything in Portugal, but your local distributor will have an obligation to inform INFARMED that they are making a product avaliable on the market. They will need the DoC to do this.
 

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