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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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White paper - Medical device registration in Brazil
Medical device registration process in Brazil
Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but rather complex. It's important to
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Brazil registration webinar 2018
WATCH NOW: Brazil ANVISA Medical Device Registration
Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a
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In Depth: Brazil Medical Device Approval and Compliance
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
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Brazil QMS Requirements For Medical Device Manufacturers
Thinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The
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Brazil ANVISA Regulatory Approval Process for IVDs
Manufacturers need to obtain ANVISA (​ Agência Nacional de Vigilância Sanitária ) approval prior to selling their products in Brazil. Brazil has four
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Introduction to Brazil's Medical Device Approval Process
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
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Overview of the IVD regulatory landscape in Brazil
Overview of the IVD regulatory landscape in Brazil
Want to sell your IVD in Brazil? Brazil regulators made sweeping regulatory changes in 2015, especially for IVDs. In particular, they consolidated
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