The rdc 362015 implements several new features, such as the examples below, but you need a detailed reading on the. The collegiate board of directors of the brazilian health surveillance agency, in the use of the attributions vested in it under article 15. New brazils anvisa rules expand facilities for investors. The rdc also improved companies reported concerns about timing of filling the requests of i updating of data. The resolution provides for migration from the cadastre to the notification for medical devices of class i. Hence, the deadline for providing such requests was set on a case by case basis by rdc no.
Anvisa publishes four new major resolutions on june 25, 2018. Rdc 2752002 da anvisa em resumo e simplificada ifope blog. The collegiate board of directors of the brazilian national health surveillance agency anvisa, in the. Under rdc 2152018 link in portuguese, the roles of federal, statelevel and local anvisa branches in the brazilian medical device regulatory process are mapped out and clarified. Article 3 distributors and storage agents of medical devices and in vitro diagnostic devices shall meet the requirements of this resolution, as applicable. Home forums hoopdirt forum rdc no 185 01 anvisa guidelines tagged. Viewing 1 post of 1 total author posts february 21, 2019 at 9. This resolution applies to equipment, health use materials and in. Condicoes higienicosanitarias e fisicoestruturais da area. Anvisa published today, 27 august 2015, the drc 362015 resolution repealing the rdc 20606 and rdc 6111 resolutions, establishing in this way, new rules for risk rating, registration, registration, labelling and instructions for use products for in vitro diagnostic ivd.
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