Maddalena Marcon -

The Competent Authority for the evaluation of the advertising concerning medical devices in Italy is the Ministry of Health (MoH).

Manufacturers of medical devices can request the authorization for any promotional item addressed to public following a specific procedure including the payment of a fee.

Before submission to the MoH, the promotional item shall be revised to check compliance with the guidelines published by the MoH.

Following the submission to the MoH, the advertisement addressed to public is assessed by a specific Commission and the outcome of the assessment process can be:

  • approval by silent consent (no comments are raised within 45 days as of submission date)
  • approval with request for changes before starting the promotional campaign
  • rejection

Any approved advertisement item is valid for 2 years and any change needs to be submitted to the Authority.

After the expiry date, the advertisement item has to be re-submitted.

Regulatory Pharma Net is available to provide full regulatory assistance for local promotional activities, including strategic support for new advertising campaigns, review of advertisement items, submission and follow-up with the Competent Authority.

Contact us at

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