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

Lingua

Do you want to market your medical devices in the united kingdom?

    Following Brexit, the United Kingdom has started to introduce new rules for the marketing of medical devices (MDs)...

Cannabidiolo ad uso orale

CBD preparations for oral use derived from cannabis extracts in the narcotic tables, the Ministry Decree and the Regional Administrative Court suspension

The decree of the Ministry of Health of 7 August 2023 “Revocation of decree 28 October 2020 of «Suspension of...

dispositivi medici su misura

New registration procedure for manufacturers of custom-made medical devices

A “custom-made device” means any device specifically made in accordance with a written prescription (…) which gives specific design characteristics,...

Digitalizzazione farmaci

EU RA procedures go digital: the new application form format (eAF) and the new product data format (PMS) – update July 2023

The European Medicine Agency (EMA) is working on the digitalisation of regulatory processes for medicines with the aim of facilitating...

Use of forbidden claims on food supplements

The use of food supplements in Italy is increasingly widespread, but at the same time the presence on the market...

Unindustria

Di Renzo Regulatory Affairs is part of Unindustria

Di Renzo Regulatory Affairs has become a member of Unindustria, a regional association that is part of the system of...

Sante DI Renzo

What are the regulatory affairs today?

It is a lesson from great masters that the more you know a subject the easier you will be able...

Ricerca scientifica per Farmaci Orfani

What are orphan drugs?

What are orphan drugs? Why are they important? Is there any incentive for their development? Orphan drugs are medicines developed...

Quality Management System for medical devices/in vitro diagnostics (DM/IVD)

The Quality Management System (QMS) is a control system, i.e. a set of activities aimed at verifying that the outcomes...