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, 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:
Freyr with a global presence and proven expertise in RoW markets, assists manufacturers for Medical Device registration. As a proven Regulatory partner, Freyr guides the RoW market entrants with the information on compliance best practices.