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Medical Device Registration in LATAM


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 for medical device registration 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 for medical device registration 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
  • Requirement for a Medical device Authorized Representative

To overcome these challenges, manufacturers should consider employing potential Regulatory partner who has the proven expertise in navigating through this promising region and is a also a reputed local Medical device Authorized Representative.

Freyr Expertise and Advantages

Freyr Expertise

  • Designing focused Regulatory strategy and plan for market-entry
  • Regulatory Intelligence to resolve premarket approval queries
  • End-to-end Medical Device Registration and Regulatory Compliance expertise
  • Medical Device License / Medical Device Notification
  • Handling submission and post submission queries
  • Qualified team of experts with hands-on experience across all major device categories
  • Quality Management System (QMS) Compliance strategy
  • Local representation services

Freyr Advantages

  • Successful submissions for varied class of devices ranging from software to sutures
  • Local affiliate access to meet challenges of authority and language specific requirements
  • Centralized Regulatory support for multiple countries
  • Support supplemented with services of Authorised Representative role