Medical device registration for class three devices, such as a catheter ablator, can be a long and difficult process. The regulatory requirements vary greatly by country and potentially overlap and benefit one another. Determining the order in which to enter specific countries greatly depends on the size of the potential market and the costs and time needed for regulatory approval. Prior approval on major facets such as clinical trials may greatly reduce the costs of entering a particular country if the data from an outside source is deemed acceptable. This creates a complex problem where start-ups who cannot afford to pursue regulatory approval in all major markets simultaneously must carefully chose and enter individual markets a few at a time.
Worcester Polytechnic Institute
Major Qualifying Project
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