Feb 25, 2019
South America
#WebinarWednesday is almost here! Join us on February 27th at 11am EST to discuss upcoming medical device regulatory changes in Brazil with our guest speaker, Marcelo Antunes, a highly qualified regulatory strategy consultant based in the country. About him Marcelo...
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Feb 22, 2019
South America
Article gives overview of the medical device regulations in Colombia. The institution responsible for medical device regulations in Colombia is INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos). INVIMA, similarly to the EU, uses a risk-based...
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Feb 10, 2019
South America
Lets talk about current medical device regulations in Mexico. Medical devices in Mexico are regulated by the Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency classifies...
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Jan 17, 2019
South America
In Brazil, the institution that oversees medical device regulations is the Brazilian National Health Surveillance Agency (ANVISA). The beginning of the medical device registration process requires the classification of the device according to the level of risk it...
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Jan 9, 2019
South America
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) is the institution responsible for regulating medical devices in Argentina. ANMAT uses a risk-based classification system and, similarly to the European Union and Canada, classifies medical...
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Nov 8, 2018
Africa
Although medical device companies are not required to comply with ISO 13485:2016 until March of next year, the International Organization for Standardization (ISO) Technical Management Board is contemplating rewriting the quality systems standard. The group that...
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