CDSCO notifies draft standard evaluation protocols for issuing IVD licenses
The protocols are meant to be followed by the country's
IVD manufacturers testing labs
and the regulator has sought stakeholders' comments over the notified draft by August 25.
'These protocols are now being placed in the public domain for comments from relevant stakeholders. This window of opportunity will close on 25th August 2025, and, once finalized, there will be minimal scope for change in these documents,' the notice reads.
The 180-page document details the standard performance evaluation and field evaluation protocol for 15 types of IVDs including Dengue, Malaria, Influenza virus, Nipah virus, Chandipura virus, SARS-CoV-2 molecular detection differentiation assay, among several others.
In Vitro Diagnostics (IVDs) are medical devices used to test samples such as blood, urine, or tissue outside the human body, to diagnose diseases, conditions, or infections, and to monitor a person's health based on predefined bio markers.
Under the Medical Device Rules of 2017, 'Licensure of In-Vitro Diagnostics (IVDs) requires a detailed evaluation protocol for the
performance evaluation of IVDs
to evaluate their quality and performance.'
The evaluation protocol helps to test the device safety, sensitivity, and accuracy, to validate the device clinical and analytical performance, required for issuing the product license, thereby allowing its usage in the country.
In India the ICMR develops evaluation protocols to standardize the process of assessing the performance of diagnostic kits, particularly In Vitro Diagnostics (IVDs) and the CDSCO oversees the evaluation and enforcement of the protocols.
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