Medical Device Registration in LATAM

Overview

The Latin American region has developed into a thriving market for Medical Device manufacturers, looking ahead for an ecological business venture. Medical Device manufacturers have been discovering a wealth of opportunity in Latin America. The major challenge and significant hindrance in obtaining medical device premarket approval in this market is, the unfamiliarity with the local Regulatory environment. But also, the fact that there are not many Medical Device manufacturers in this region, makes it more compelling for the manufacturers of other regions to gain access in these regions. Below are some of the challenges which may make medical device registration difficult for LATAM markets.

• Absence of common Regulatory platform for the region
• Different language requirements in diverse countries
• Separate requirements for GMP and Clinical trial requirements
• Continuously evolving Regulatory standards in different countries
• Catering approved translation requirement into the local language before submission
• Communication with agency during approval and query handling situations
• Highly fragmented distributor environment in these region device marketing

To overcome these challenges, manufacturers should consider employing potential Regulatory partner who has the proven expertise in navigating through this promising region.