EU MDR/IVDR
The institution responsible for medical device regulations in Spain is Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), a state agency within the Spanish Ministry of Health, Social Services and Equality. Spain, just like all the other members of the...
Europe
In Austria, the institution that oversees the regulation of medical devices is the Austrian Federal Office for Safety in Health Care (BASG). Medical devices in Austria are classified into the following three categories: Active implantable medical devices General...
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...
Asia
The National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA), is the institution responsible for pharmaceuticals and medical devices regulations in China. Similarly to the FDA in the United States, the NMPA classifies...
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...
EU MDR/IVDR
The European Union has established the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as replacements to the Medical Devices Directive (MDD) and ln Vitro Diagnostic Devices Directive (IVDD), which had previously been in place for almost 25...
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