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Food labels

Italian consumers pay more and more attention to the information reported in labels and to the quality of the products they are...

Clinical trials of medical devices in the European Regulation 2017/745

On 11 March 2021 Di Renzo Regulatory Affairs attended a digital event on clinical trials with medical devices, and the impact...

Food supplements – updates on regulations

The world of food supplements is under continuous development and growth. More and more Italian and foreign companies are opting...

Adverse reactions, the role of regulatory agencies in the pharmacovigilance

The onset of unexpected adverse reaction and the measures to be taken to protect patients’ health have been very much debated lately....

Functions and benefits of production lot

All manufacturing activities provide for the attribution of a lot number for each batch of manufactured goods; this is even more...

AIFA clarifies the simplified procedure for generics classification in class C

Last 15 October, the Italian Medicine Agency had announced the introduction of a new simplified price and reimbursement procedure for...

Export of cosmetic products to China

The presence of products made in China and marketed in Europe and in Italy is often talked about. Several types of product...

MedDRA, the importance of harmonisation

In a world that is more and more globalised, managing international issues was made easier by legal and procedural harmonisation in every...

Orthotics and insoles: Are they medical devices? Do they need CE marking?

Some product groups can put manufacturers in a difficult position, as they are not always able to place their product...

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