Europe
In Croatia, the governmental body responsible for regulating medical devices is the Agency for Medicinal Products and Medical Devices (HALMED). Devices are categorized into the following classes based on the risk they pose toward on the human body: Class I, Class IIa,...
EU MDR/IVDR
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
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
This article provides a general overview of the current medical device regulations in the Czech Republic. The State Institute for Drug Control, or Státní ústav pro kontrolu léčiv (SUKL) in Czech, is the government institution responsible for the regulation and...
South America
In Peru, the institution responsible for the regulation of medical devices is the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID). Medical devices in Peru are classified into four different classes depending on their associated risk: Class I — Low...
South America
This post will tell you more about medical device regulations in Uruguay. The institution responsible for regulating medical devices in Uruguay is the Ministerio de Salud Publica (MSP). Medical devices in Uruguay are categorized into six classes (Category 1 to...
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