O documento, assinado pelo ministro da justica, jose eduardo cardozo. A guide to brazils medical device requirements nist. A guide for importing medical equipment into brazil. Rdc 37 2011 biowaiver portuguese rdc 602014 new and generic drug products portuguese revoked. Guidance document degradation profiles of drug products portuguese faq rdc 732016 portuguese guidance document. The executive board of the brazilian national health surveillance agency anvisa, in exercise of the attributions vested under section 4 in article 11 of the anvisa statue approved by decree no.
Rdc 2552018 anvisa statute portuguese rdc 2832019 nitrosamines portuguese. Brazil medical device regulations anvisa guidelines. Rdc 172010 drug product gmp portuguese rdc 312010 pharmaceutical equivalence portuguese rdc 37 2011 biowaiver portuguese rdc 602014 new and generic drug products portuguese revoked. Rdc 732016 postapproval changes of drug products portuguese rdc 2002017 new and generic drug products portuguese. A guide for importing medical equipment into brazil 1. The purpose of this alert is to inform members and clients about the compliance requirements. General overview of the brazilian regulatory framework 3. Anvisa s resolution rdc no 72 of 29 december 2009 concerning minimum requirements for the promotion of health at the health control ports located nationwide and the vessels calling those ports rdc 72. Comprehensive list of medical device regulations for medical devices sold in brazil. Resolu o federal rdc 412012 altera a resolu o federal rdc 44. Consultation of the draft from 0630 2011 to 08 29 2011 pc 33 2011 publication of rdc 27 on may 2012.
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