Masotti Cassella was honoured to participate in the BIO International Convention 2026, where Luca Masotti was invited to speak on the legal and regulatory aspects of market entry into Italy for international healthcare companies.
Held within the Italian Pavilion, the presentation offered a practical overview of the Italian legal and regulatory framework, the main commercial structures available to international operators, and the key contractual and compliance considerations affecting access to the Italian healthcare market.
The session focused on the implications for companies operating in the medical devices, biotechnology and pharmaceutical sectors, with particular attention to innovation, clinical development, market authorisations, distribution models and relationships with public and private healthcare operators.
Italian and EU regulatory rules for medical devices, pharmaceuticals and biotech innovation.
Clinical investigations, trials, authorisations and the transition toward market access.
Distributor, commercial agent, subsidiary or branch, and joint venture arrangements.
Commercial, procurement, compliance, liability and contractual issues for foreign investors.
Italian healthcare demand, innovation funding and opportunities linked to the PNRR.
Practical considerations for entering the Italian and broader European healthcare market.
The presentation formed part of the Invest in Italy programme promoted by the Italian Trade Agency, highlighting Italy as a strategic healthcare and life sciences market and an attractive destination for international investment.
Supporting healthcare innovation across borders
Masotti Cassella assists domestic and international clients throughout every stage of their entry into the Italian and European markets, from regulatory assessment and contractual structuring to commercial implementation and long-term market development.