Guia de certificação de dispositivos de terapia LED: Como verificar o FDA, CE/MDR, Mdl, TGA, ISO, MDSAP, Ul, e registros de teste
TL;DR (for B2B buyers) First classify the product: a medical / therapeutic LED device and a general beauty electrical appliance do not need the same evidence package. Do not stop at “FDA registered.” Ask for the FDA 510(k) número, covered models, uso pretendido, product codes, and clearance documentation. For regulated-market products, verify market records and […]