This book - the first in a planned series of ExportMED books on developing markets - describes and analyzes trends, key issues, and events in Brazil's medical devices sector, to assist U.S. small- and medium-sized enterprises (SMEs) in making educated business decisions about entering that market. The book examines the medical devices industries, including its domestic medical devices and diagnostics market and the best market opportunities and sales prospects for U.S. SMEs. The book also considers economic, cultural, and political factors influencing Brazil's medical devices market. Finally, the book provides information on market entry requirements and strategies for SMEs, and U.S. Department of Commerce and other resources to help U.S. firms in their market entry endeavors. Appendices list useful contacts in the United States and Brazil, as well as recent statistics for medical devices exports to Brazil and further information about Brazilian medical devices associations. This book is based on market research and analysis undertaken in Brazil in 2002-03, including several trips by the OMMI Director Jeffrey Gren, Medical Devices Team Leader Richard Paddock and International Trade Specialists Jay Biggs and Kimberly Shaw. Mr. Gren and Mr. Paddock interviewed government officials, industry trade associations, industry analysts, and government officials in Brasilia and Sao Paulo, Brazil. U.S. Commercial Service (USCS) market specialists in Brazil attended these interviews and actively supported this work. Supplemental information gathered from on-site interviews and a review of available literature are also included in this book. Ms. Shaw attended the ABPVS International Regulatory Conference in Recife, Brazil, from September 3 - 5, 2003. In the body of the book, Brazilian terms are presented in English translation, accompanied occasionally by the original Portuguese words in parenthesis. A glossary of terms and abbreviations is provided for quick reference."