This episode explores the critical decision of who holds your INVIMA medical device registration in Colombia. We delve into the significant business risks of allowing a distributor to be the registration holder and outline the strategic advantages of using an independent third party. Learn about the process for transferring ownership, the potential pitfalls of an uncooperative distributor, and how to maintain full control over your commercial strategy in this key Latin American market.

• What is an INVIMA Registration Holder and why does it critically impact your business?

• Are you exposing your company to risk by letting your distributor control your market access?

• How does an independent registration holder provide commercial flexibility?

• What is the official process for switching your registration holder in Colombia?

• What happens if your current distributor refuses to transfer the registration?

• Can you work with multiple distributors under a single registration?

• How can you avoid being locked into a single commercial partner?

• What is the best practice for new companies entering the Colombian market?

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.