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 travelling to Italy to pick up the Smart Card which is necessary for the electronic signature.
As Authorized Representative MDSS went through the process and now offers this notification service to all medical device manufacturers who wish to avoid certain pitfalls.
Please note: According to recent changes the Italian Ministry of Health has abolished the €100 fee which so far was necessary to inscribe products into the "Repertoiro"
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
Phone: +49 511 6262 8630
Fax: +49 511 6262 8633
Or Click Here for our Contact Form
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