For medical device manufacturers, gaining access to multiple major markets is usually an important factor in the economic success of new and advanced medical technologies. At the same time, the checkered global landscape for the regulatory approval of new devices typically requires manufacturers to demonstrate compliance with different and often seemingly conflicting regulations and requirements. These differences and discrepancies typically result in a long and costly path to global regulatory approval.
Taking a strategic approach in achieving regulatory approval can be an effective tool in reducing the compliance burden facing medical device manufacturers. Manufacturers who first obtain approval from the U.S. Food and Drug Administration (FDA) for access to the U.S. market can often leverage that approval to gain a prompt and efficient review of new device applications by regulators in other markets. This can result in faster and wider deployment of new medical technologies, and help to more quickly generate increased revenue from the sale of new medical devices.
This UL white paper will discuss the importance of developing a regulatory compliance strategy for the acceptance of medical devices in major medical device markets around the world. Beginning with an overview of the general regulatory frameworks found in major jurisdictions, the paper then discusses the process for obtaining medical device clearance in the U.S., and how device manufacturers can leverage FDA clearance to achieve acceptance in other countries. The white paper concludes with some recommended steps that manufacturers can take to help ensure the prompt and efficient review and approval of medical devices by regulators.