EU MDR/IVDR
MEDICAL DEVICE REGULATIONS IN FINLAND 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...
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...
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...
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