South America
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) is the institution responsible for regulating medical devices in Argentina.
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...
Australia and Oceania
The institution that oversees medical devices in Australia is the Therapeutic Goods Administration (TGA). The TGA has established the Australian Regulatory Guidelines for Medical Devices (ARGMD), which closely resembles the regulations put into place by the European...
North America
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and...
Asia
For the last 70 years, only a handful of medical devices have been regulated in Pakistan under its Drug Act of 1976. In an attempt to control the quality of the devices being sold and used in the country, the Drug Regulatory Authority passed the Medical Device Rules...
