REGULATORY FRAMEWORK FOR IN-VTRO DIAGNOSTICS IN EU, USA AND INDIA

Healthcare now includes a variety of practical products and technologies for diagnosis, prevention, treatment, and disease control. In vitro diagnostic medical devices (IVDs) are some of these medical technologies, used alone or in combination, and are used by manufacturers to test laboratory samples of human origin to provide information of diagnosis for monitoring or compliance purposes. CE Mark/Certification is required for in vitro diagnostic medical devices (IVDR) sold in the European Union. IVDR is regulated in a new way by certification bodies and national authorities. The certification body ensures compliance with quality and safety standards and IVD certification with the CE mark, which is a marketing authorization issued by a competent authority of a Member State. IVD regulation in the United States is administered by the CDRH. In order to obtain a marketing permit, strict adherence to the desired principles is required. 510(k) and PMA are the regulatory pathways for obtaining marketing authorization in the United States. In India, CDSCO regulates a small number of IVDs through official news notifications. Some products are classified as drugs in India and devices in other countries. This system does not meet international standards. The existing regime appears to be more traditional than the US and EU regulatory regimes. In this review, we will discuss IVD, MDR, regulation and labeling of Ce.