Regulatory Services in Italy

The Italian Medicines Agency, or Agenzia Italiana del Farmaco (AIFA), is the national authority that regulates medicinal products and biologics and falls under the Ministry of Health (Ministero della Salute). After careful evaluation of the safety, efficacy, and quality data of medicinal products, the marketing authorization application must be submitted to AIFA or EMA. For Expert medical devices Services, prior authorization is not required however the device must be compliant to the legislative decree 46/1997 and undergo rigorous testing for verification. In order to be placed on the market, medical devices must obtain a CE mark. As of May 2022, a new legislative decree Regulation (EU) 2017/746 on in vitro diagnostic medical devices, adopted in 2017, became fully applicable and officially replaced the previous legislative decree. The major regulatory changes include new device classification systems where manufacturers could find their in-vitro diagnostic medical device to fall under in higher risk classes. Subsequently, this would require increased efforts in notifying regulatory bodies in order to maintain compliance. This requires marketing authorization holders to be consistently updated with the latest changes in legislations.

As a leading global contender, DDReg’s Regulatory Services in Italy provide ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.