Medical Device Registration Consulting for the Italian Market

Registration of Medical Devices in Italy

We help with the requirements regarding registering medical products in Italy

New decrees request manufacturers of medical devices to perform a specific registration procedure in Italy before placing their products on the Italian medical device market.

These two decrees (“Decreto del Ministero della Salute” & “Decreto Ministeriale”), issued by the Italian Ministry of Health (MoH) in 2007 on February 20th and May 20th respectively, are the legal basis for the procedure, requiring:

1. Notification of new products since 1st May 2007.
2. Notification of products already placed onto the Italian Market until 1st January 2009.

The new requirements apply to medical devices (class I-III), complete systems, kits and active implantable medical devices. They do not cover custom-made devices, in vitro diagnostic medical devices or devices intended for clinical studies.

Complexity of the Registration Procedure

As a German company MT Promedt Consulting is officially authorized to perform product registration in Italy for European and Non-European manufacturers.

Devices need to be registered into a new official electronic database of the Italian MoH.
The access to the database system requires a specific Italian authorization. During the complex product registration process major parts of the technical product documentation need to be submitted.

By appointing us as your independent representative for the Italy registration process, you will keep the highest flexibility in your distribution network. We do guarantee protection of your confidential information and documentation.

For further information please contact Carlo Mascia: mascia(at)mt-procons.com