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AMERICAS
BRAZIL
Market Information
Brazil’s healthcare expenditure: In the year 2022, over 136 billion reals were allocated by the Brazilian government towards healthcare, with a substantial portion of that amount, approximately 45%, specifically directed to hospital and outpatient services, totaling nearly 62.2 billion Brazilian reals.
Market Trend: The healthcare insurance market in Brazil is anticipated to experience growth, increasing from $50.66 billion in 2022 to reach $98.01 billion by 2030. This represents a Compound Annual Growth Rate (CAGR) of 8.6% over the forecast period spanning from 2022 to 2030.
Brazil’s medical equipment market is anticipating an annual growth rate (CAGR 2024-2028) of 7.07%, leading to a market volume of US$13.67 billion by 2028.
Established in 1999 during President Fernando Henrique Cardoso's tenure, the Brazilian Health Regulatory Agency (Anvisa - Agência Nacional de Vigilância Sanitária) serves as a regulatory entity under the Brazilian government. Its primary responsibilities encompass the regulation and approval of pharmaceutical drugs, enforcement of sanitary standards, and oversight of the food industry.
Medical Device Regulation
Brazilian Health Regulatory Agency (Anvisa), under the MOH.
Classification, Fees, Timeline
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Product Registration Routes
Class I, II, III, IV
Useful Information
Validity of License: Class I & II - no expiry. Class III & IV - 5 years.
License transfer: They are required to execute the transfer contract and request ANVISA to nullify the registration in their name.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
