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Medical Device Registration - RoW Market


Medical Device Registration Overview

Rest of the World (RoW) markets provide an exciting opportunity for global Medical Device manufacturers, in terms of ease of approval, market size and competitive edge. But at the same time, medical device registration in RoW markets also present a lot of country specific Regulatory and cultural challenges, which impact the overall approval journey of the Medical Device.

Following are the major challenges faced by Medical Device manufacturers during the Medical Device registration process in RoW markets:

  • Compliance challenges, such as, Medical Device registration requirements differ from country to country
  • Lack of formal in-depth guideline on key commercialization aspects, such as, clinical and other physical testing requirements
  • Continuously evolving Regulatory standards in different countries
  • Local language translation requirements and hence the need of a trusted local medical device authorized representative
  • Difficulty in communicating with the agency during approval and query handling situations

Our medical device Experts with a global presence and proven expertise in RoW markets with the help of a local medical device authorized representative, assists manufacturers for Medical Device registration. As a proven Regulatory partner, Our medical device Experts guides the RoW market entrants with the information on compliance best practices. 

Freyr Expertise and Advantages

Freyr Expertise

  • Designing focused Regulatory strategy and plan for market entry
  • Regulatory intelligence to resolve premarket queries
  • End-to-end Medical Device Registration and Regulatory Compliance expertise
  • Handling submission and post submission queries 
  • Local representation

Freyr Advantages

  • Qualified team of experts with hands-on experience across all the major Medical Device categories
  • Global presence with local expertise for on-ground support
  • Centralized Regulatory support for multiple countries
  • Operational flexibility
  • Support for region specific Regulatory complexities and challenges