ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country spotlighted on the cover of Market Pathways' print issue. The February 2025 cover features Brazilian Health Regulatory Agency (ANVISA) headquarters in Brasília.
Regulation
Authority: Brazilian Health Regulatory Agency (ANVISA)
Leader: Antonio Barra Torres, Director-President of ANVISA
Points Of Interest:
- ANVISA, established in 1999, turned 26 on January 26.
- Class I-II devices are subject to simple notification, while higher-risk Class III-IV devices undergo a technical file review to reach market.
- In 2024, ANVISA said it reduced review times by about 80% for devices already authorized in the US, Australia, Canada, or Japan, leveraging its new Reliance program.
- ANVISA has initiated new requirements over the past five years for manufacturers of certain implantable devices to disclose prices based on technological attributes, data which is presented public “economic monitoring” databases
Market Access
Authorities: Ministry of Health; National Commission for Incorporation of Technologies (CONITEC)
Leader: Nísia Trindade Lima, Minister of Health
Points Of Interest:
- The National Commission for Incorporation of Technologies (CONITEC) conducts technology assessments informing what devices are used by the health system.
- Brazil’s universal public health system is coordinated by the Ministry of Health, with roles for state and municipal governments.
- About 25% of the population supplements public care with private insurance.
More Resources
- ANVISA’s international affairs official Augusto Geyer presented regulatory updates before the International Medical Device.
- The Commonwealth Fund provides a detailed overview of Brazil’s healthcare system
- More details from Market Pathways on the origins of ANVISAs economic monitoring databases
