|
 The Central Drugs Standard Control Organisation (CDSCO) has released the draft standards for In-Vitro Diagnostics (IVD) medical devices evaluation protocol, drafted by the Indian Council of Medical Research (ICMR) and the drugs regulator, inviting comments from the stakeholders.
The standards are developed for use by IVD manufacturers testing labs in India, as the licensure of IVDs under Medical Devices Rules 2017 requires a detailed evaluation protocol for the performance evaluation of these devices to evaluate their quality and performance.
As part of the performance evaluation standards, the regulator has specified in the draft standards that after following due procedure as defined in the document, once any kit is found to be Not of Standard Quality, thereafter, no request for repeat testing of the same kit will be acceptable.
"Any request of re-validation from the same manufacturer for the same test type will only be entertained after a minimum of 3 months and only if a high-level technical summary of modifications or functional improvements to the kit design is submitted, without explicit disclosure of proprietary information," it added.
The draft also added that for all these tests, clinical samples are precious, therefore, repeat evaluation of a kit using the same r different well-characterized sample panel at a different laboratory may be considered only for kits which claim high performance characteristics (sensitivity and specificity 95% and above), but which fail the performance evaluation by a margin of 5%.
The performance evaluation protocols has been developed by ICMR and CDSCO for 15 IVDs including influenza virus molecular detection or differentiation assay (Single plex and multiplex format), SARS-Cov-2 molecular detection assay (Single plex/multiplex), respiratory syncytial virus molecular detection assay (Single plex/multiplex), influenza virus and SARS-CoV-2 molecular detection differentiation assay (multiplex format), malaria rapid diagnostic test (RDT) for P Falciparum and P Vivax, malaria ELISA assay, malaria real time PCR assay, malaria RDT kits, Nipah virus and Chandipura virus real time PCR, multiplex respiratory virus RT PCR, dengue IgG RDT, Dengue IgM/IgG combo RDT, and Dengue IgG ELISA tests.
"These protocols are now being placed in the public domain for comments from relevant stakeholders," said the CDSCO.
"This window of opportunity will close on 25th August 2025, and, once finalized, there will be minimal scope for change in these documents. Therefore, all interested stakeholders are requested to provide their comments before 25th August 2025...." it added, providing the email address to share the response in a prescribed format.
Once the public consultation period concludes, all comments will be reviewed and considered in finalising the draft protocols before final clearance by ICMR and CDSCO, said the regulator.
|