This episode explores a crucial, often overlooked aspect of entering the Chilean medical device market: the selection of an in-country registration holder. We detail the significant risks of appointing a distributor as your registration holder with the Instituto de Salud Pública (ISP), including loss of market control and conflicts of interest. The discussion then shifts to the strategic advantages of using an independent, third-party representative, which ensures manufacturers retain full ownership and flexibility over their product registrations and commercial strategy.

• Why is choosing your registration holder in Chile a critical strategic decision?

• What are the hidden risks of letting your distributor own your product registration?

• How can a distributor legally hold your market access hostage?

• What is the primary conflict of interest when a distributor manages your regulatory compliance?

• How does appointing an independent holder give you complete control over your commercial strategy?

• What is the role of the Instituto de Salud Pública (ISP) in medical device registration?

• Can you switch distributors easily if they are your registration holder?

• How does an independent holder model protect your company's long-term interests?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.