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FDA defines a medical device as any product that does not achieve its purposes by chemical action or metabolization. Correctly classifying a medical device is crucial for outlining the regulatory requirements and standard that it need to comply to and the regulatory strategy for its registration with FDA.
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 South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.