FDA Medical Registration
The management of medical devices by the FDA is carried out through the Center for Devices and Radiological Health (CDRH), which supervises the production, packaging, and distributors of medical devices to comply with legal regulations in their business activities.The range of medical devices is very wide, ranging from medical gloves to cardiac pacemakers, all of which are under FDA supervision. Based on their medical use and potential harm to the human body, the FDA classifies medical devices into categories I, II, and III, with higher categories providing more supervision.If the product is a novel invention that has never existed in the market, the FDA requires manufacturers to conduct rigorous human experiments and have convincing medical and statistical evidence to demonstrate the effectiveness and safety of the product.The FDA certification of medical devices includes: manufacturer registration with FDA, product registration with FDA, product launch registration (510 form registra...
2017
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06
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