Italy – Medical Device Registration (NSIS)

Medical Device Registration In Italy

Regulatory Authority of Italy 

Directorate General for Medical Devices, Pharmaceutical Services and Safety in Healthcare (La Direzione general dei dispositivi medici, del servizio farmaceutico e della sicurezza delle cure svolge) deals with the implementation of medical device regulations, preventing and dealing with clinical risk, regulating the advertising of medical products, and providing medical-legal consultancy to state institutions. 

Registration Requirement 

All medical devices marketed in the EU must bear the CE mark to certify conformity with EU law. In Italy, the Manufacturer must register the medical devices in a dedicated database of the Ministry of Health before they are put into the market. 

The obligation to register with the new modalities concerns medical devices marketed in Italy for the first time starting from 1 May 2007, and in particular: 

Entities making the registrations: 

The registration of a device within the Database / Directory of Medical Devices system can be requested by:

If the manufacturer is headquartered outside the European Union, the requirements under the Portuguese regulation must be completed by a legal representative in the Community or, European Authorized Representative (AR). 

A single AR may only represent the manufacturer for each type of device. Thus, to enter the medical devices market, manufacturers of medical devices are required to appoint an AR, which will assist with all the details regarding the registration process and assist in completing requirements under the Italian regulation. 

As a non-EU manufacturer of medical devices, the manufacturer’s legal representative can appoint a “delegate as person or company” to register their product with the Italian database. This delegate will communicate with the Italian Ministry of Health on the manufacturer’s behalf.  

The online registration can be found on the Ministry of Health website: http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=395&area=dispositivi medici&menu=registrazione. 

Timeline for registration: 1 month 

Registration Process for NSIS

Process for Non-EU Manufacturer  

Documentation Requirement 

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