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. 

Additionally, when marketing a device which is a predicate device to USFDA, the manufacturers are required to prove substantial equivalence by submitting a 510(k) application, a Premarket Approval application (PMA). Understanding the requirements and checking for exemptions of premarket notification [510(k)] will save time and resources for manufacturer before deciding upon submission. Apart from 510(k) notification, Freyr strategizes Regulatory roadmap for 513(g) applications, also.

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. With a vast network of affiliates spanning across globe, Freyr can also procure local agent services to market the device across multiple markets.


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 [510(k)] Technical File Preparation
  • 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 510 (k) & 513(g) Applications 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