Medical Devices Regulatory Framework & Update: Brazil (November 2021)

26 pages. Brazil represents the biggest market for medical devices in South America. Its medical devices are regulated by the Brazilian National Health Surveillance Agency (ANVISA), in accordance with the Brazilian Resolution RDC 185/2001, which are largely taken from the European Medical Device Directive (MDD). It was worth noting that a foreign company is required to appoint a local partner company that is legally constituted in Brazil, as the registration holder who will be responsible to submit the device's registration application to ANVISA and maintaining the device's registration after approval. Some medical devices will require extra certification for approval such as the National Institute of Metrology, Standardization and Industrial Quality (INMETRO) certification and Brazil Good Manufacturing Practice Certificate (BGMP). Selling and marketing medical devices in Brazil can be a complex process in complying with the legislation and standards, however, ANVISA has simplified the approval process throughout the years especially for low-risk devices.