Analytical Performance Reports (APR)
Need help preparing or reviewing your Analytical Performance Report? Introduction IVDR Analytical Performance – Explained the Easy Way Under the EU IVDR 2017/746, every in vitro diagnostic device (IVD) must prove that it performs correctly and safely before being sold in the European Union. This proof comes from performance evaluation, which includes three parts: scientific […]
(ICMR–CDSCO) : Draft Protocol for Evaluating Diagnostic Kits – Respiratory Viruses, Malaria, Dengue, and Emerging Pathogens
India’s New IVD Rules: The Big Change Every Manufacturer Must Know! In India, every company that makes or imports In-Vitro Diagnostic (IVD) kits like tests for flu, COVID-19, dengue, malaria, etc. must get their products checked and approved before selling them. To do this, the Central Drugs Standard Control Organisation (CDSCO) and the Indian Council […]