§ COMPARE REGULATORS

CDSCO vs ANVISA: Medical Device Regulatory Comparison

Compare the medical device registration pathways, classification, and regulatory requirements of CDSCO (India) vs ANVISA (Brazil).

CDSCO

Central Drugs Standard Control Organization (India)

India

India's CDSCO regulates medical devices under the Medical Devices Rules 2017 (amended 2020). India uses a four-class system (A, B, C, D). India is the fastest-growing major medical device market globa…

CLASSES

Class A, B, C, D

PATHWAY

CDSCO registration / import license

KEY FUNCTIONS

▸Medical device registration
▸Import license (Form MD-14)
▸Clinical investigation approval
▸Quality management system audit
▸Adverse event reporting

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