Clinical trials: studies of the absorption, distribution, metabolism and excretion of relevant drugs under controlled artificial conditions, using specific diseased or healthy populations as subjects, with the aim of discovering and confirming the effectiveness and safety of interventions for the treatment, prevention or diagnosis of specific diseases, as well as for confirming their effectiveness and safety

According to the requirements of the US FDA, manufacturers (including OEM processors) exporting finished and semi-finished medical devices to the US market should register their businesses in the US FDA system.