Medical Device Registration in The Americas

The United States (US) medical device market is regulated by the US Food and Drug Administration (FDA), and manufacturers are required to navigate the registration pathways based on device risk classification to place their devices on the market. Freyr's expertise encompasses Regulatory intelligence and strategy, product classification, identification of US FDA's registration pathways (510(k)/De-NOVO/PMA/IDE), and more.

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Medical Device Registration Overview

U.S. & Canada are the most lucrative markets for medical devices in terms of market acceptance as well as in terms of existent regulations required for necessary licenses and approvals. With a strong demand for high-quality medical device technologies, the U.S. and Canada markets continue to attract manufacturers worldwide. But tracking, decoding, and aligning with region-specific medical device Regulatory requirements, at times, poses a challengein medical device registration, for manufacturers, if not implemented intelligently. For example, U.S. requires all importing companies to appoint a registered U.S. agent to act as a connection between the company and the USFDA.

Head quartered in Princeton, NJ, U.S., Freyr has strong capabilities in the region and provides end-to-end Regulatory support to varied classes of Medical Devices ranging from software based to In-Vitro Diagnostic (IVD) Devices.

Our Presence

The Unites States of America is a highly regulated and competitive market with scores of medical devices and IVDs receiving approvals each year. Medical devices in USA are regulated by the Center for Devices and Radiological Health (CDRH) under the Food and Drug Administration (FDA).

Medical Device Registration USA

CDRH Medical Device approvals in the US are achieved through any of the registration pathways. The appropriate pathway is determined by a risk-based medical device classification system.

Medical Device Classification USA

Device ClassRiskRegistration Pathway for approval
ILow Risk510(k) exempt
II

Moderate Risk

(With predicate device)

Premarket Notification/510(k)

Moderate Risk

(Without Predicate Device)

De-Novo application
IIIHigh RiskPremarket Approval (PMA)

Companies lacking a local presence in the U.S. are required to appoint a U.S. Agent.

Canada has one of most stringent regulatory systems for medical devices. All the medical devices in Canada are regulated by Health Canada

Medical Device Registration Canada

Regulatory pathway is determined upon risk-based classification of the device.

Device ClassRiskRegulatory Pathway
ILowMedical Device Establishment License (MDEL)
IILow-ModerateMedical Device License (MDL)
IIIHigh-ModerateMedical Device License (MDL)
IVHighMedical Device License (MDL)

There is no requirement for the manufacturer to appoint an Authorized Representative in Canada.

Freyr’s Medical Device Device Registration Services

Medical Device Registration in The Americas

  • Regulatory and Market Intelligence Support
  • Product Classification as per Regulatory requirements
  • Medical Device Registration USA -513 (G) & (Right Pathway among 510 (K)/De-NOVO/PMA/IDE) 
  • Pre-Submission Meeting with Health Agencies
  • Regulatory Support for Product Documents such as, Design History File (DHF)
  • Gap Analysis of the Technical Documents & Good Manufacturing Practice (GMP) Systems
  • Regulatory Support for Technical File Compilation as required by respective Registration Pathway
  • USFDA Quality System Compliance Strategy (21 CFR 820)
  • Medical Device Single Audit Program (MDSAP) compliance services
  • Medical Device Registration Canada-Medical Device License (MDL) and Medical Device Establishment License (MDEL) Registration
  • Health Agency Liaising and support
  • In-Country Representation – U.S. Agent and Sanitary Responsible Person Services
  • Post Approval Compliance activities
  • Successful submissions for varied class of devices ranging from software to sutures
  • Local affiliate access to meet the challenges of authority and language-specific requirements
  • Dedicated and expert personnel to provide Medical Device and IVD Regulatory support
  • Cost-effective model for In-country or Legal representation support
  • Have successfully delivered various projects across U.S. and Canada
  • Headquartered in the U.S.