Overview

The United States of America (USA) & 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 USA and Canada markets continue to attract manufacturers worldwide. But tracking, decoding, and aligning with region-specific medical device Regulatory requirements, at times, poses a challenge for manufacturers if not implemented intelligently. For example, US requires all importing companies to appoint a registered United States Food and Drug Administration (USFDA) agent to act as a connection between the company and the USFDA.

Freyr has strong capabilities in the region and provides end-to-end Regulatory support to the varied classes of medical devices ranging from software based to In-Vitro Diagnostic (IVD) devices.

 

Freyr Expertise

  • Product classification as per Regulatory requirements
  • Gap Analysis of the Technical documents & Good Manufacturing Practice (GMP) systems
  • Regulatory Support for Product development documents such as Design History files
  • Regulatory support for Technical file compilation [510(k)]
  • Regulatory and Market Intelligence support
  • Health Agency Liaising and Support
  • Health Canada-Medical Device License (MDL) and Medical Device Establishment License (MDEL) Registration
  • Canadian Medical Devices Conformity Assessment System (CMDCAS), Medical Device Single Audit Program (MDSAP) and Health Canada ISO 13485 Quality Management System (QMS) Compliance
  • USFDA 513 (g) & 510 (k) Strategy
  • USFDA Quality System Compliance Strategy (21 CFR 820)
  • Mexico (COFEPRIS) Registration and Approval Strategy
  • Country Representation and Post Registration Assistance
  • Unique Device Identifier (UDI) expertise for GUDID submissions
 

Freyr Advantages

  • 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
  • Headquartered in the USA