The brazilian health regulatory agency anvisa is an autarchy linked to the ministry of health, part of the brazilian national health system sus as the coordinator of the brazilian health regulatory system snvs, present throughout the national territory. Brazil medical device regulations anvisa guidelines. On june 30th 2010, without any prior announcement, resolution rdc no. Ministerio da saude pagina inicial da anvisa anvisa. Comprehensive list of medical device regulations for medical devices sold in brazil. Mapping of applicable technical regulations, conformity assessment. The collegiate board of director of the brazilian national health surveillance agency anvisa. Federal public service ministry of development, industry and. Specific norms and standards from abnt brazilian association of technical. National sanitary surveillance agency, ministry of health. Legislacao em vigilancia sanitaria resolucao rdc n. We also can help you register your medical devices with anvisa. Technical regulation of standard operating procedures applied to producerfood industrialization establishments and the checklist of good manufacturing practices in food producingindustrializing establishments.
National sanitary surveillance agency, ministry of health, brazil 2002 resolution rdc no. Condicoes higienicosanitarias e fisicoestruturais da area. Exporting products regulated by anvisa to brazil might include the need for specific premarket authorizations issued by regulatory bodies in brazil. The brazilian health regulatory agency anvisa, an agency under the. Access to unregistered drugs was already available previously by rdc 261999 to patients in brazil through the expanded access program, anvisa told biopharm. Anvisa conducts international inspections to verify good manufacturing practices in companies that manufacture drugs, medical devices and apis that are to be imported and marketed in brazil.
A guide to brazil toiletry, perfume and cosmetic products. Resolution rdc 2752002 technical standard operating regulation. For this, 21 establishments were visited, assessed using a checklist based on the checklist contained in board resolution n. A valid gmp certificate is a requirement for anvisa to issue a market authorization for these products. Anvisa questions and answers of the resolution rdc 53.
293 1085 319 1555 560 15 1358 440 959 1592 764 1407 109 279 886 810 516 871 925 780 256 251 1419 1442 1141 1482 1059 279 1444 683 249 677 648 631 1522 1048 711 526 1626 260 1052 1030 1165 1081 541 478 357 754 549 721 597