Standard IVD Evaluation Protocols –
Drafted by ICMR and CDSCO
Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly issued the Draft Standard IVD Evaluation Protocols
The document outlines the need for standardized evaluation protocols for IVDs as mandated by the Medical Devices Rules 2017. These protocols are essential to ensure the quality and performance of diagnostic kits used in India
Several specific performance evaluation protocols have been drafted, including those for:
a. Chikungunya IgM ELISA
b. Dengue NS1 RDT and ELISA
c. Zika virus real-time PCR , among others
The document includes detailed guidelines for evaluating various IVDs, emphasizing:
i. Study design and ethical considerations
ii.Requirements for evaluation sites and laboratory standards
iii.Procedures for conducting diagnostic accuracy studies
iv.Acceptance criteria for sensitivity and specificity of tests.
This initiative by ICMR and CDSCO aims to enhance the reliability of diagnostic testing in India through structured evaluation processes, ensuring that manufacturers adhere to high standards of quality in their products. Stakeholder engagement is critical to refining these protocols before their final adoption.
Stakeholders are invited to provide comments on these protocols until February 15, 2025.
Comments should be submitted via email before 15th February 2025, at ivdevaluation@gmail.com as per the specified format given in the notification
Source: https://www.icmr.gov.in/icmrobject/uploads/WhatsNew/1735801120_advt_ivd_document.pdf
