Post-Market Requirements As in many other developed and emerging markets, Brazil’s medical de

Post-Market Requirements
As in many other developed and emerging markets, Brazil’s medical device regulators require post-market surveillance once a product is commercialized in the country. ANVISA post-market requirements are on par with those in markets such as the European Union. Your BRH must maintain records on your device and notify Brazil’s National Health Surveillance System of any adverse events, recalls or major health threats tied to the device.


Reference:
  1. http://brazilianhealthdevices.com/en/market


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