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

Freyr 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, Freyr guides the RoW market entrants with the information on compliance best practices.