US Food and Drug Administration (FDA)
The US FDA conducts regular inspections of Arjo’s production units to ensure regulatory compliance. The FDA requires that Arjo complies with the quality system regulation for medical devices in the US. Arjo’s MDSAP certification confirms that these requirements have been met.
Health Canada Medical Device Regulation
Health Canada regulates products in accordance with the Canadian food and drugs legislation, which also covers medical devices. This is achieved by evaluating medical devices to assess their safety, effectiveness and quality before being approved for sale in Canada. Health Canada requires that Arjo is MDSAP-certified to be able to sell medical devices on the Canadian market.
EU Medical Device Regulation (MDR) and United Kingdom (UKCA)
In December 2023 Arjo received its final Medical Device Regulation (MDR) and UKCA certificates for the EU and the United Kingdom respectively. The completed certifications ensure that Arjo products can continue to be sold to European and UK customers with a valid CE or UKCA mark.