Resources

Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

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Get smart about Brazil in 1 hour
If you are thinking about entering the Brazilian market for the first time, understanding ANVISA’s regulatory requirements can be overwhelming.
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What To Expect From Your Regulatory Representative
Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if
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Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device
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Learn about the Brazilian ANVISA regulations which apply to medical devices
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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ANVISA - Brazil National Health Surveillance Agency
The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible
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Learn about basic demographic and healthcare market data on Brazil
BRAZIL – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and healthcare market data on Brazil, plus specific information about the medical device and healthcare
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Health Canada: Structure and Overview
Health Canada is a federal department responsible for the national public health of Canadians. It regulates the use of consumer goods, drugs,
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