Entering the North American medical device market requires navigating two highly regulated yet interconnected systems—the U.S. FDA and Health Canada. From U.S. medical device registration and establishment listing to obtaining Canadian Medical Device Licenses (MDL) and Medical Device Establishment Licenses (MDEL), every step demands precision, planning, and regulatory clarity.

Masuu Global Solutions supports manufacturers, importers, and startups with an integrated U.S.–Canada market access strategy. We interpret requirements, define optimal regulatory pathways, and guide you seamlessly from development to approval and ongoing compliance.

Medical Device Registration in the U.S. & Canada

The North American market is one of the largest and most regulated medical device ecosystems in the world.
  • In the United States, device approval and oversight fall under the FDA’s Center for Devices and Radiological Health (CDRH).
  • In Canada, medical devices are governed by Health Canada under a risk based classification system.
Both countries use similar risk based classes, but with variations:
  • U.S.: Class I, II, III
  • Canada: Class I, II, III, IV
Manufacturers must demonstrate safety, effectiveness, and quality through:
  • Strong technical documentation
  • A compliant Quality Management System (QMS) aligned with ISO 13485
  • Programs such as MDSAP, which streamline audits across major markets

Masuu Global Solutions helps unify your U.S. and Canadian regulatory strategy—aligning classification, technical evidence, QMS readiness, and submissions so you can accelerate approvals in both markets using a single, harmonized approach.

Masuu’s Medical Device Registration Services (Americas)

Expertise

  • Regulatory and market intelligence for U.S. and Canada
  • Product classification according to FDA and Health Canada rules
  • U.S. medical device registration: 513(g) assessments and the correct pathway (510(k), De Novo, PMA, IDE)
  • Pre Submission meetings with FDA or Health Canada
  • Support preparing Design History File (DHF) and other product documentation
  • Gap analysis for technical files and Good Manufacturing Practice (GMP) systems
  • Full support for technical file compilation for each required pathway
  • U.S. FDA Quality System compliance strategy (21 CFR 820 / forthcoming QMSR)
  • MDSAP compliance assistance
  • Canada MDL and MDEL application support
  • Liaising directly with regulatory authorities
  • In country representation as U.S. Agent and Canadian Regulatory Representative
  • Post approval support and lifecycle compliance

Advantages of Working With Masuu in the Americas

  • Proven success across all device classes—from SaMD to high risk implantables
  • Local affiliates to meet authority specific, language, and documentation needs
  • A dedicated team specializing in U.S. FDA and Health Canada submissions
  • Cost effective options for U.S. Agent and Canadian regulatory representation
  • Strong track record delivering projects across the U.S. and Canada
  • U.S.-anchored presence for efficient communication and real time support

Why Partner With Masuu Global Solutions?

  • End to end North America regulatory expertise—from submissions to post market surveillance
  • Proven success across 1500+ medical device registrations globally, including U.S. Class I–III and Canada Class I–IV devices
  • On ground support through U.S. Agent services and Canadian representation
  • Integrated U.S.–Canada regulatory strategy to minimize duplication, reduce costs, and shorten timelines
  • Direct engagement with FDA and Health Canada for faster, clearer communication
  • Trusted by 470+ medical device manufacturers—from emerging startups to global leaders
Book a Demo