Article 3 distributors and storage agents of medical devices and in vitro diagnostic devices shall meet the requirements of this resolution, as applicable. A guide to brazils medical device requirements nist. Comprehensive list of medical device regulations for medical devices sold in brazil. We also can help you register your medical devices with anvisa. Lei estadual le n 3312001 regulamentada pelo decreto estadual n. A guide for importing medical equipment into brazil 1. Rdc 37 2011 biowaiver portuguese rdc 602014 new and generic drug products portuguese revoked. A guide for importing medical equipment into brazil. O documento, assinado pelo ministro da justica, jose eduardo cardozo. Guidance document degradation profiles of drug products portuguese faq rdc 732016 portuguese guidance document. Brazil medical device regulations anvisa guidelines. Rdc 732016 postapproval changes of drug products portuguese rdc 2002017 new and generic drug products portuguese.
Comunidades terapeuticas sao regulamentadas ministerio da justica. General overview of the brazilian regulatory framework 3. Rdc 2552018 anvisa statute portuguese rdc 2832019 nitrosamines portuguese. 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. Consultation of the draft from 0630 2011 to 08 29 2011 pc 33 2011 publication of rdc 27 on may 2012. 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. The purpose of this alert is to inform members and clients about the compliance requirements.
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