Although different countries have varied regulations for medical devices, the fundamental principles are the safety and effectiveness of the medical device for their intended uses. According to these two principles, medical device administrations and agencies classify devices into different classes based on their risk levels. After classification, administrations are able to apply specific regulations to these devices. Classification helps the medical device and IVD industries to have a basic idea of to what extent of material they need to provide for regulatory compliance. Once knowing the class of the device, firms need to prepare a sufficient amount of reports and tests to support and convince administrations that the device is safe and effective to its intended use. Also, administrations usually require firms to register devices in order to better monitor and track medical devices after entering markets. Once all the requirements are completed and have satisfied the regulations, administrations will give premarket clearance or approval. AcmeBiotechs Consulting provides assistance in complying with these regulations across different countries. Learn more about regulatory differences between countries at our Knowledge Center.