Every commercial In Vitro diagnostic medical device manufacturer must go through the process of classifying their devices according to the regulatory requirements to get global market approval. Determining the correct classification of IVD is one of the most important stages of the device’s life cycle. Classification of an IVD device to an appropriate risk class is done using a set of harmonized classification principles based on intended use, which allows regulatory authorities to rule upon matters of interpretation for a particular IVD medical device.
This whitepaper gives a glimpse of the regulatory device classification of major countries like United States of America, Europe, Canada, Australia, China and Japan along with the challenges in IVD. Most of the countries follow device classification requirements based on European Union In Vitro Diagnostic Regulations (EU IVDR) or United States Code of Federal Regulations (CFR) by the US Food and Drug Administration (US FDA). Download to continue reading.