Effective February 6, 2010, all medical device manufacturers will need to comply with the Italian Health Ministry’s revised decree that regulates medical device registration.
Italy — A New Ministry of Health Decree Should Simplify the Registration Process for Medical Devices
The new decree, published on 21 December 2009, replaces the controversial decree of 20 February 2007 (Decreto del Ministero della Salute 20 febbraio 2007) which required medical device manufacturers, or their affiliates, to register their products in the Italian Ministry of Health Database, if the medical devices were to be sold in Italy. IVDs were excluded from this decree, since they needed to be registered through a separate process.
Medical Device Registration
This new decree is meant to reduce the amount of data that has to be supplied by companies when re-registering products in several categories including class I devices and active implantable devices.
According to the Italian Ministry of Health, this new directive should simplify the requirements for the registration of medical devices. The deadline by which older products must be re-registered has been extended until 5 May 2010.
U.S. companies need to comply with the revised registration process.
The question, however, is whether or not the registration process for medical devices in Italy will indeed be simplified with this new decree.