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...
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...
RegDesk News/Info
“So is RegDesk essentially a regulatory consulting firm?” Questions like these haunt everyone on the ours team. More often than not, inquisitors are quick to slap the “consulting firm” label onto the RegDesk name when attempting to categorize the company. But the...
#WednesdayWebinar Join us for our upcoming webinar Global Regulatory Changes to Expect in 2025 January 22, 2025 at 10 AM ET
Register Now
