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:

  • Class I, IIa, IIb and III devices.
  • The kits and assemblies.
  • Active implantable devices.

Entities making the registrations: 

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

  • Manufacturer
  • Representative
  • Other delegated subject by the manufacturer and representative

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: Ministry of Health

Timeline for registration: 1 month

Registration Process for NSIS

  • Register and electronically sign the data of the registrant who intends to carry out the notification of medical devices.
  • Register and electronically sign the data of device Manufacturers and/or Authorised Representatives other than the reporting Authorised Representative.
  • Enter the device data in the system.
  • Complete device data entry or correct entry errors/inaccuracies entered upon inserting.
  • Verify that the data entered complies with system controls.
  • Sign data electronically and submit the application.

Process for Non-EU Manufacturer  

  • Designation of European Authorised Representative
  • Provide your European Authorised Representative with relevant documentation
  • Document review
  • Foreign company’s legal representative detects the individual (whether Italian or not) or the company to delegate for entering data.
  • Registration on the Ministry of Health Database (NSIS)

Documentation Requirement 

  • Name and code of the medical device, its classification, name of the Manufacturer or its authorized representative, a brief description of the medical device together with its intended use, a list of the materials contained in the medical device that comes into direct contact with the patient, sterilization data, information about re-use, scientific bibliography and other information.
  • CE Conformity Certificates
  • EC Declaration of Conformity (must be in Italian)
  • Packaging box (Box, Labelling and instructions for use (must be in Italian))
  • Technical file
  • Scientific bibliography supporting the clinical evidence of the effectiveness and safety of the device
  • Data Sheet
  • Commercial Data

What We Offer 

  • Act as your AR in the EU
  • Register your medical devices in the Italian Database.
  • Keep you up to date with the Italian regulatory requirement.
  • Help you with translation of User Manual and Labelling into Italian.

Why Choose Us  

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory Affairs solutions

Contact us for free consultation: info@omcmedical.co.uk