ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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Global Insights - Devices & IVDs
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Oct 45 min read
ANVISA's Post-Approval Changes in Medical Devices in Brazil : RDC 340/2020
ANVISA (Agência Nacional de Vigilância Sanitária), Brazil's health regulatory agency, plays a crucial role in ensuring the safety and...
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Oct 27 min read
ANVISA Regulation of SaMD in Brazil : RDC 657/2022
The landscape of healthcare technology is rapidly evolving, and software as a medical device (SaMD) is at the forefront of this change....
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Sep 276 min read
ANVISA Medical Device Registration in Brazil :Reliance Pathway (IN 290/2024)
The registration of medical devices in Brazil is a critical step for manufacturers looking to enter this expansive market. ANVISA...
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Sep 166 min read
ANVISA RDC 687/2022 : BGMP Certification for Medical Devices in Brazil
As the Brazilian market continues to grow in prominence, ensuring that medical devices meet the highest quality standards is crucial. The...
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Sep 155 min read
ANVISA Regulation of IVDs in Brazil : Resolution RDC 830/2023
Over the past two years, Brazil's regulatory landscape for medical devices has undergone substantial changes. In 2022 and 2023, Brazil’s...
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Sep 88 min read
Regulation of Medical Devices in Brazil: ANATEL Certification
In Brazil, medical devices must adhere to rigorous regulatory standards to ensure their safety, effectiveness, and quality. A key element...
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Sep 68 min read
Regulation of Medical Devices in Brazil: INMETRO Certification
Entering the Brazilian market with medical devices requires overcoming various regulatory challenges to ensure safety and compliance....
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Sep 38 min read
ANVISA Regulation of Medical devices in Brazil
Brazil, the largest economy in Latin America, has a well-established and complex regulatory framework for medical devices. As the...
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