Brazil QMS Requirements For Medical Device Manufacturers
Download this white paper for an overview of medical device QMS requirements in Brazil.
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CONTACT USThinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The changing legislative landscape combined with the limited resources at the Brazilian Health Surveillance Agency (ANVISA) often cause frustration for domestic and foreign manufacturers.
But if you are willing to put in the effort, the Brazilian market has potential. In this 9-page white paper, we'll answer your biggest questions about regulatory requirements for medical device manufacturers in Brazil, including:
- What is Brazilian medical device/IVD GMP?
- Who must meet BGMP requirements?
- What is the submission process?
- What does the future hold for GMP requirements in Brazil?
You'll learn all this and more in this white paper.
About the Author:
Michael Dun, RAC is the Australia Country Manager and Director at Emergo. He has more than 13 years of experience in quality systems, auditing, regulatory affairs, and research and development across the biotechnology, IVD and medical device manufacturing and services industries. His areas of expertise include QMS implementation and audits, risk management, and device registration and documentation in the US, EU, Brazil, and Australia.
Related
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Brazil ANVISA Medical Device Regulations
All documents listed below were published by ANVISA in Portuguese and translated by Emergo into English. Use the English for informational purposes
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Brazil ANVISA Regulatory Approval Process for Medical Devices
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