Registration and repertory (RDM)

REGISTRATION OF MEDICAL DEVICES IN THE DATABASE OF THE ITALIAN MINISTRY OF HEALTH AND REGISTRATION IN THE REPERTORY (RDM)

The registration of data relating to medical devices have been is defined by the Decree of 21 December 2009 and subsequent updates.

Coronati Consulting is able, upon delegation of the Manufacturer, to register medical devices in the Database of the Italian Ministry of Health and in the Directory according to the methods indicated in the Ministerial Decree of 21 December 2009. We provide qualified technical assistance throughout the Notification process also for foreign companies that have Italian distributors and that market their medical devices to the Italian National Health Service (SSN).

Service included are:

– support for correct identification of single device, assembly or kit

– Search and identification of CND (classificazione nazionale dispositivi) code and GMDN (global device nomenclature)

– Preparation and classification of documentation in electronic format

– Registration in the database of the Italian Ministry of Health

– Management of any reports from the Italian Ministry of Health

– Registration in the DM Repertoire for devices that can be sold to the Italian National Health Service (SSN)

– Data update for registered devices

LINK

Ministero della Salute Italiano – Dispositivi Medici

CND – Classificazione Nazionale dei Dispositivi Medici

Repertorio dei dispositivi medici