+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


Pubblicità dei dispositivi medici

Medical devices advertising

Medical device (MD) advertising is regulated by article 21 of Legislative Decree 24 February 1997. In particular, this article forbids to advertise to the general public any MDs that can be sold only on doctors’ prescription or be used with the assistance of a doctor or other health professionals, and establishes that advertising to the public of medical devices other than those mentioned above is subject to an authorization by the Ministry of Health.

To this end, the manufacturer or any subject responsible for the marketing of a product shall apply for the authorisation for health advertising submitting a specific request to the Ministry of Health. 

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for medical devices and can assist companies in the following activities: 

  • advice on the regulations in force
  • detailed examination of the company’s documentation prior to its submission to the Ministry of Health
  • preparation of the advertising authorisation application, submission to the Ministry and administrative process.

Moreover, thanks to its international cooperation with several consultants in the EU countries, Di Renzo Regulatory Affairs can also take care of authorisation procedures for medical device promotional advertisements in other Member States.

Foto di Jobbeat da Pixabay