New Delhi, Aug. 29 -- The Central Drugs Standard Control Organisation (CDSCO), India's top drug regulatory body, has released draft protocols for the approval of In-Vitro Diagnostic (IVD) devices used in the detection of Tuberculosis (TB), including drug-resistant TB.
IVDs are medical devices used to test samples such as blood, urine, or tissue outside the body, helping in the diagnosis and monitoring of diseases. Under the Medical Device Rules, 2017, all such devices must undergo a rigorous performance evaluation before receiving a licence.
The 53-page draft outlines standard procedures to assess the analytical and clinical performance of IVDs meant for diagnosing Pulmonary TB and Drug-Resistant TB (DR-TB). These protocols are aimed at e...