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MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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National Registration Italy

 National Registration of Medical Devices with the Italian Authority

According to the Italian Decree of December 21, 2009 manufacturers are obliged to register their class IIa, IIb and III  medical devices in Italy.  The registration of risk class I products is voluntary.

The  registration  into  the databank of the Italian Ministry of Health  must be made online. To get access to the databank you have to apply for an authorization from part of the Authorities.   In addition, a smart card is required to digitally sign the data.

The specific authorization procedure for the submission of the national registration is very complex and may take several weeks including traveling to Italy to pick up the Smart Card which is necessary for the electronic signature. 

As Authorized Representative MDSS has gone through the process and now offers this notification service to all medical device manufacturers who wish to avoid certain pitfalls.

Appoint MDSS to perform the  Italian National Registration on your behalf

Outsourcing registration processes and delegating this obligation to an independent entity helps you to keep the highest business flexibility in your distribution network.  We guarantee that all information and documentation will be handled with utmost confidentiality.

 

Our service includes:

  • access to the Italian database
  • consultancy on the data requirements
  • communication in Italian language with the Competent Authority
  • advice regarding the classification of your devices into the Italian nomenclature system
  • insertion of the relevant product information into the Italian database
  • the necessary digital signature
Custom-made devices must be also notified in Italy. The procedure differs from the notification of medical devices. Please contact us for further information.

Medical Device Safety Service GmbH
MDSS Consultancy Division
Schiffgraben 41
30175 Hannover
Germany

Phone: +49 511 6262 8630
Fax: +49 511 6262 8633

Or click here for our Contact Form.