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BioWorld - Wednesday, June 4, 2025
Home » Topics » Regions » Latin America

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Mexico’s COFEPRIS adds SaMD to definitions in revised labeling rule

May 7, 2024
By Mark McCarty
Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms.
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Brazil’s new medical device rules starting in March promise to simplify process

Jan. 25, 2023
By Sergio Held
Brazilian health care regulator Anvisa unveiled new medical device rules that promise to simplify over two decades of accumulated directives, putting into force changes announced by the health care surveillance agency in 2022.
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Proxalutamide study once again in Brazilian crosshairs

Aug. 30, 2022
By Mari Serebrov
Brazilian regulatory agency Anvisa reported that it is participating in an investigation that launched Aug. 25 into alleged crimes of smuggling, misrepresenting, distributing and delivering proxalutamide related to a clinical trial in Brazil.
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Companies race to conquer the Monkeypox IVD market in Brazil

Aug. 25, 2022
By Sergio Held
Five companies have applied for marketing authorizations in Brazil to deliver rapid test kits to diagnose monkeypox cases in real time.
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Henlius establishing big biosimilar deals in Latin America

June 7, 2022
By Sergio Held
Two major deals inked by Shanghai Henlius Biotech Inc. in May confirm the company’s plans to invest heavily in the Latin American market.
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Henlius establishing big biosimilar deals in Latin America

June 1, 2022
By Sergio Held
Two major deals inked by Shanghai Henlius Biotech Inc. in May confirm the company’s plans to invest heavily in the Latin American market.
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Brazilian flag

Brazil readies to adopt SaMD regulation

May 27, 2022
By Sergio Held
Brazil’s health care regulator plans to start enforcing in July new regulations for software as a medical device (SaMD), clearing up doubts about its oversight over intangible health care assets such as software.
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Nugen device in use

Nugen sets its sights on US and Mexican type 1 diabetes markets

Feb. 25, 2022
By David Godkin
A needle-free injection system for patients with diabetes developed by Nugen Medical Devices Inc. has been approved for use in 40 countries but until now has yet to crack the North American market. Nugen said it is now gearing up for FDA and Mexican approval of the Nugen MD needle-free injector following Health Canada’s approval of the system less than a month after the Toronto med tech went public in late 2021.
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Latin America’s med-tech sector faces steep hurdles

Dec. 31, 2021
By Sergio Held
The med-tech industry across Latin America continues to grow, but the growth is uneven, concentrated in a handful of countries and faces significant challenges. A report released in December by the United Nations Economic Commission for Latin America and the Caribbean (ECLAC) reveals the complexity of the region's med-tech trade balance and underscores the main challenges for the industry in the region, whose performance was also impacted by the COVID-19 pandemic.
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Promising results drive push for Paxlovid compulsory license

Dec. 7, 2021
By Mari Serebrov
Although Pfizer Inc.’s COVID-19 oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), has yet to be authorized anywhere, the push for compulsory licensing of the drug has begun.
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