FDA Circular "Guidelines on the Regulation of Medical Device Software (MDSW) by the Food and Drug Administration (FDA)"; (7 page(s), in English)

Draft Regulatory Decree about Law No. 15.022/2024 (28 pages, in Portuguese; 30 pages, in English).

Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System; (3 page(s), in English)