The regulation that describes the procedures for obtaining gmp certification by anvisa is resolution rdc 3920, as amended by resolution rdc 152014. Rdc helps compliance teams around the globe by delivering powerful, decisionready intelligence and worldclass risk and compliance protection. Rdc regulatory datacorp advanced kycaml customer screening. Medicamento rdc 6014 principio ativo rdc 452012 estabilidade excipientes embalagem rdc 7109 rotulagem rdc 4709 bula estudos in vitro rdc 3110 eqfar re 012005 estabilidade rdc 89903 validacao rdc 58 impurezas nt 03 dissolucao estudos in vivo re 0915 ddcm re 1170 be bpf rdc 1710 27.
Mapping of applicable technical regulations, conformity assessment. The collegiate board of directors of the brazilian national health surveillance agency anvisa, in the. We also can help you register your medical devices with anvisa. Anvisa uses mdsap audit reports for brazilian gmp certification purposes. Makes provisions on the administrative procedures for granting good manufacturing practice certification and good distribution andor storage practice certification. Don is a thorough professional with excellent subject matter knowledge. Confirm that the manufacturer has identified the possible hazards associated with the. Administrative procedures for gmp, en pt, rdc 3920, 20. Were proud to announce we have agreed to be acquired by moodys, which furthers the reach, information, and analytics we.
Brazilian good manufacturing practices rdc anvisa 1620, japan ordinance on. The collegiate board of the national health surveillance agency, in the exercise of the attributions granted by. F aplicavel d ao fabricante i aplicavel ao importador distribuidor armazenador checklist n. Requirements for proof of gmp for registration processes of healthcare products en en pt. In 20, anvisa adopted a set of measures to modernize. Were proud to announce we have agreed to be acquired by moodys, which furthers the reach, information, and analytics we can deliver in the fight against financial crime. Furthermore, manufacturers inspected by anvisa may follow different. Requirements for economic information report en en pt. The collegiate board of the national health surveillance agency, in. Brazil medical device regulations anvisa guidelines. Ficam revogados a resolucao da diretoria colegiada rdc n. Anvisa is a part of nsss national system of sanitary surveillance nsss is an organization of brazil whose responsibility is to keep a watch over certain professional activities to put a stop to charlatanism to inspect ships, cemeteries and places where food was on sale to the public.
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