Medical Device Consulting Services for Brazil

Emergo Group helps medical device manufacturers obtain ANVISA approval to sell their products in Brazil. We can assist with a variety of issues, ranging from medical device registration and B-GMP compliance to Brazilian Registration Holder representation and distributor qualification. With offices in Brazil, North America, Europe and Asia, we are ready to help you access the fast growing Brazilian market.

Medical Device Approval from ANVISA

Our team in the city of Brasilia (the capital of Brazil) is experienced with a wide range of medical devices and has a long working relationship with ANVISA, Brazil's regulatory agency.

Brazil GMP Quality System Compliance Consulting

We can fully assist you in modifying your existing quality management system to comply with Brazil GMP requirements from ANVISA.

Brazil Registration Holder Representation for Medical Device Manufacturers

Emergo Brazil, with offices in Brasilia, can act as your independent regulatory liaison with ANVISA, Brazil's National Health Surveillance Agency.

Finding New Medical Distributors in Brazil

EDM Services, a division of Emergo  Group, can help you find, qualify, select and manage distribution partners in key Brazilian cities.

Medical Device Classification Consulting

If you need assistance determining the proper classification of your medical device according to ANVISA resolution RDC 185/01, our team in Brazil is ready to help.

Click on the image to download this PDF of the medical device approval process in Brazil