Advertising for Medical Devices, Only if Authorized

Regardless of the chosen format, whether print, social media, website, radio, or short film, advertising of medical devices to the public must be authorized by the Ministry of Health.

The approval process takes 45 days and requires payment of a fee of €380.10 for each text, for each product, and for each medium of distribution.
So: 1 print text, related to 3 products, 1 medium of distribution (for example, a social media post) = €1,140.30

Penalties and Rules

To obtain authorization, it is essential to comply with requirements that vary based on the medium of distribution.
To provide clarity, the Ministry of Health has published 7 different documents, on subsequent dates, each adding information to the previous one. Therefore, all 7 are valid simultaneously and available here.

In detail:

• Guidelines of 17/02/2010
• Guidelines of 28/03/2013
• Guidelines of 20/12/2017
• Use of testimonials of 20/12/2017
• Integration for Facebook advertising of 24/10/2019
• Advertising of condoms of 06/10/2020
• Statement on advertising surgical masks of 21/10/2020

Clearly, it’s impossible to hope to summarize the content in an article, but it’s important to know that the level of detail of the specifications contained in the guidelines is quite high.
For example, if advertising for medical devices is done through a Facebook post, reactions and comments must be disabled. Or, on Instagram, advertising can be done only through stories with swipe up that link to the manufacturer’s website. Not through a post.

In short, to avoid submitting non-compliant texts to the Ministry or managing advertising incorrectly, we are available.

Although many companies don’t even know they need to request authorization, ignoring this exposes them to a significant economic risk. Advertising medical devices without authorization carries a penalty of €2,582 to €15,493 (Legislative Decree 219/2006).

Validity

Legislative Decree 219/2006 also specifies the period of validity of the authorization, which is 2 years.
It remains valid that the Ministry may consider applicable a shorter period of validity, for example in cases where the text contains the words “new” or “novelty”; for such a message, the authorization lasts for one year.

How to Apply

The detailed procedures are specified on the Ministry of Health’s website, the request can be made via certified email (PEC).

Address: dgfdm@postacert.sanita.it
Subject: DM-PUB-A01
Include in the subject: Request for authorization of health advertising product name, medium of distribution, company protocol

Attached to the request, it is necessary to provide: a copy of the payment receipt, a stamped copy of the advertising text with two €16 revenue stamps, a copy of the ID of the person submitting the request.

Advertising to Healthcare Professionals

The advertising subject to authorization is exclusively that directed to the public. If directed to healthcare professionals, it does not require any of this.

It often happens, in fact, that when opening the website of a medical device manufacturer, a pop-up appears: “I declare that I am a healthcare professional.”
One click and you’re in.