What we do
We register your medical devices
As you might know, according to the Ministry of Health Decree (DM) issued on December 21, 2009, the registration of any medical devices in the Italian Database and Repertory of Medical Devices (RDM) is mandatory to sell them to Italian hospitals.
Therefore, we will assist you to get your products registered as fast as possible by putting you in contact with your registration provider that will take care of the registration process.
The registration of medical devices usually takes a couple of weeks only, however this might vary depending on the complexity of your products and the availability of the requested documentation for the registration.
The following technical documentation is mandatory to get your products registered in the RDM:
- CE mark certificate.
- Labeling and instructions for use in Italian.
- Product description.
Additional technical documentation might speed up the registration process, particularly for the correct classification of your products according to the new Classification of Medical Devices (CND), which is a mandatory step in the registration process in the RDM.
If your products’ labeling and instructions for use are not available in Italian yet, we can assist you in the translation of these documents by putting you in contact with professional translators specialized in the field of technical documentation for medical devices.
If your products are not CE marked yet, one of our registration providers will also take care of it by working with a Notified Body that will provide CE mark registration to your products according to the European Directives.
In summary, for all your needs relative to the registration of your products in the RDM, you will have one single point of contact, your registration provider, which will take care of everything you need to this end. And we will, of course, assist you in each and every step until the registration of your products is completed.
Since 2004 we have provided regulatory consulting, directly and through our registration providers, to dozens of foreign manufacturers of medical devices, and since 2010 we have already registered more than 400 new products in the RDM. And counting …