South America
This article 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 del Ministerio de Salud Publica y Bienestar Social (MSPBS). Medical devices in...
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...
Europe
In Bulgaria, the institution that regulates medical devices is the Bulgarian Drug Agency (BDA). On June 12, 2007 the Bulgarian Parliament created the Law on Medical Devices, which is the policy that is currently used to govern the registration of medical devices...
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...
Europe
Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to bring a device to market. These regulations are generally quite complex, but such complexity...
EU MDR/IVDR
The institution responsible for medical device and pharmaceutical regulations in the United Kingdom is the Medicines and Healthcare products Regulatory Agency (MHRA). MHRA was formed in 2003 and its headquarters are located in London, England. In April 2013, MHRA...
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