Brazilian Drug and Medical Device Regulation: A Practical Guide

January 2013

The Food and Drug Law Institute (FDLI) is pleased to provide Brazilian Drug and Medical Device Regulation: A Practical Guide as a companion product to our pioneering conference, U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device, and Food Law and Regulation. With this practical book and the groundbreaking 2012 Brazil conference, FDLI is continuing its role as a leading provider of publications and programming in the area of global food and drug law. 

Brazil is a fast-growing economy and of great interest to U.S. and international drug, medical device and food companies. Brazil is currently the eighth largest goods trading partner with $75 billion in total (twoway) goods trades during 2011. Exports were valued at $65 billion while imports were valued at $39 billion. U.S. goods and services trade with Brazil was estimated at $103 billion in 2011. In March 2011, Brazil and the U.S. signed an agreement on trade and economic cooperation and established the United States-Brazil Commission on Economic and Trade Relations, with the objective of promoting bilateral economic and trade cooperation, including intellectual property rights and regulatory issues affecting trade and investment.

The U.S. Food and Drug Administration has opened offices outside of the United States and specifically in Latin America, where it is collaborating with its counterpart, the Brazilian Health Surveillance Agency (ANVISA). U.S. drug and medical device companies wanting to do business in Brazil need to understand ANVISA procedures in administering the regulatory scheme for drugs and medical devices, as well as FDA requirements. This Practical Guide, written by experienced Brazilian lawyers and regulatory specialists, provides summaries of Brazil’s requirements for the development, approval and marketing of drugs and medical devices. This Guide also includes English translations of many relevant laws and directives. This Guide is intended to help you to take advantage of various marketing pathways and enable successful partnerships in Brazil.

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Editors:

Carlos T. Angulo and Areta L. Kupchyk

Cover: Downloadable PDF Ebook
Number of pages: 54 pages
Edition: 1st
Date published: Jan 14, 2013
ISBN:

978-1-935065-55-5

Language: English



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