The Medical Products Agency (MPA), or Läkemedelsverket (Swedish), is a government body within the Swedish Ministry of Health and Social Affairs. MPA is primarily responsible for regulating medical device, pharmaceuticals, and cosmetics and ensuring that both patients...
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...
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...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.