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Home » Topics » Regulatory » ANVISA

ANVISA
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Coronavac shipment

Brazil’s Anvisa issues emergency pathway for COVID-19 vaccines, though some firms seek other routes

Dec. 7, 2020
By Sergio Held
Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals.
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Novel coronavirus SARS-CoV-2

Chembio looks for share of competitive Brazilian market for SARS-CoV-2 tests

Dec. 2, 2020
By Sergio Held
CAJICA, Colombia – Chembio Diagnostic Systems Inc., a point-of-care diagnostic company focused on infectious diseases, received the approval from Anvisa, the Brazilian health care surveillance agency, to distribute its tests in the Latin American market. The approval adds yet another test to the hundreds already approved in Brazil, where the market for such tests is quickly getting crowded sending prices down. Brazil is one of the countries most affected by COVID-19 with almost 6 million cases and 166,000 deaths, the third highest number of cases in the world.
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Regulatory front

FDA adds to roster of regulatory science tools

Oct. 20, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIST ramps up Zero Trust cybersecurity program; TGA sets date for mesh up-classification; IMDRF posts post-market study update; ANVISA updates list of non-regulated devices.
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Brazilian flag

Cutting the red tape: Brazil eases class II registration

Oct. 8, 2020
By Sergio Held
CAJICA, Colombia – In a move to reduce bureaucratic procedures and fight backlogs, the Brazilian health care surveillance agency, Anvisa, softened its rules for the marketing authorization of class II medical devices in the Latin American country.
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REPAVID-19 study of reparixin in severe COVID-19 pneumonia approved in Brasil

Sep. 3, 2020
French flags on building

Control of medical devices in France severely criticized by the Cour des comptes

Jan. 10, 2020
By Bernard Banga
PARIS – The Cour des comptes, supreme body for auditing the use of public funds in France, independent from government and parliament, has just released its report on the operation of the French National Agency for the Safety of Medicines and Health Products (ANSM). Following 10 months of administrative and financial investigation, these financial controllers have highlighted the weakness of controls applied to medical devices placed on the market in France.
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Is Brazil moving toward a med-tech price cap?

Sep. 24, 2019
By Sergio Held
BOGOTA, Colombia – Last month, Anvisa, Brazil's health surveillance agency, approved a proposal that makes it mandatory for the agency to monitor the prices of medical implants, a category that, in Brazil, includes orthoses, prostheses and special materials. Is this the beginning of a price capping era for medical devices in the Latin American giant?
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LatAm region should improve clinical trial regulation: experts

Sep. 12, 2019
By Sergio Held
SAO PAULO, Brazil – Latin America is rife with opportunities to undertake clinical trials, but regulatory adjustments are needed for companies to fully take advantage of them. As the largest market in the region, Brazil, for one, is in dire need of those adjustments, said experts gathered in Sao Paolo last week for the annual BIO Latin America conference.
Read More

Brazilian approval for Biocon and Mylan's trastuzumab biosimilar

Dec. 29, 2017
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