The advertising of medical devices is regulated by Article 21 of the Legislative Decree of the 24 February 1997. In particular, it prohibits advertising to the general public of devices that can be sold only with a prescription from a doctor or be used possibly with the assistance of a physician or other healthcare professional, and states that advertising to the public of medical devices different from those mentioned above is subject to authorization from the Ministry of Health.
To this end, the manufacturer or person responsible for placing a product on the market must request an authorization to carry out health advertising by submitting a request to the Ministry of Health.
Di Renzo Regulatory Affairs, with his unit consisting of a pharmacist, a chemist and administrative personnel, is able to provide the following services:
- Advising on the current legislation
- Accurate examination of the documentation from the company, before being submitted to the Ministry of Health
- Preparation of the application, submission to the Ministry and monitoring of the entire bureaucratic process