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The concept of substantial equivalence of medical devices was introduced by
the US Food and Drug Administration (FDA) as part of the Medical Devices
Amendment (MDA) to the Federal Food, Drug, and Cosmetic Act (FD&C Act)
enacted on May 28, 1976.
The MDA gave the FDA authorization to issue regulations classifying all medical devices into three classes, based on the level of controls they deemed necessary to provide reasonable assurance of their safety and effectiveness
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.