Regulatory Precision at Every Level

From Class I to Class IV, we simplify the path to market for medical devices across LATAM and the Caribbean.

Where Innovation Meets Regulatory Precision.

Rebexa brings deep regulatory fluency and regional insight to help medical device companies move faster, avoid bottlenecks, and maintain long-term compliance.

Whether you’re registering surgical equipment, diagnostic tools, prosthetics, or software-based devices, we help classify your product, navigate submission requirements, and manage ongoing approvals across diverse local frameworks.

Our support includes:

  • Classification, market mapping, and registration strategy.
  • Dossier compilation (CTD, STED, or local format).
  • Import license management and legal representation.
  • Post-approval changes and renewals.
  • Local and regional submission coordination.

What Sets Us Apart?

We’ve managed over 5,000 registrations to date and maintain strong relationships with regulatory agencies across the region. From risk class assignment to dossier follow-up, we’re by your side,every step of the way.

Streamline Your Medical Device Registration

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Please contact us by completing the form below and one of our team-members will reach out to you. We look forward to assistint you.

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