§ COMPARE REGULATORS

FDA vs ANVISA: US and Brazil Medical Device Regulation

Compare FDA and ANVISA medical device registration — BRH requirements, MDSAP pathway, INMETRO certification, and Portuguese labeling.

FDA

U.S. Food and Drug Administration

United States

The FDA is the primary regulatory authority for medical devices in the United States. Its Center for Devices and Radiological Health (CDRH) oversees premarket review, postmarket surveillance, and enfo…

CLASSES

Class I, II, III

PATHWAY

510(k), PMA, De Novo, HDE

KEY FUNCTIONS

▸510(k) clearance and PMA approval
▸MAUDE adverse event database
▸FDA Enforcement Reports and recalls
▸De Novo classification
▸Breakthrough Device Designation

ANVISA

Agência Nacional de Vigilância Sanitária (Brazil)

Brazil

ANVISA regulates medical devices in Brazil using a four-class risk-based system. Brazil is an MDSAP participating country. ANVISA requires a Brazilian Registration Holder (BRH) for foreign manufacture…

CLASSES

Class I, II, III, IV

PATHWAY

ANVISA cadastro (Class I-II) / registro (Class III-IV)

KEY FUNCTIONS