South America
The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s regulating authority in the sphere of medical device circulation, has recently issued the updated rules regarding the registration of medical devices. The most important amendments...
South America
This article was updated May 30, 2025 Regulatory Framework and Governing Bodies: Peru’s regulatory framework for medical devices is primarily governed by the Law No. 29459 (Law of Pharmaceuticals, Medical Devices, and Health Products) and its amendments under Supreme...
South America
This article has been updated on May 29, 2025 and provides a general overview of the current medical device regulations in Paraguay. Medical device regulations in Paraguay are set forth by the Direccion de Viglancia Sanitaria (DINVISA) del Ministerio de Salud Publica...
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...
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...
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...
