Importer & Manufacturer | Source: CDSCO
Published On: 17-09-2025
Enforcement Date: 04 September, 2025
ICMR-CDSCO Standard Performance Evaluation Protocols
ICMR and CDSCO have issued a unified set of 39 standard protocols to evaluate IVD kits (ELISA, RDT, PCR, multiplex) for diseases including Dengue, Chikungunya, Zika, Malaria, Typhoid, TB and key respiratory viruses. The compendium standardizes study design, sample sizes, acceptance criteria, cross‑reactivity checks, and reporting templates to independently verify manufacturers’ performance claims.
The compendium lays down uniform performance‑evaluation methods for IVDs, covering analytical/field protocols, reference assays (WHO/US‑FDA/CDC/NIV approved), blinded testing, and repeatability/reproducibility requirements (lot‑to‑lot, inter‑operator, day‑to‑day).
Acceptance thresholds vary by assay type (e.g., ELISA ≥90% sensitivity/≥95% specificity; RDT ≥80%/≥90%; PCR ≥95%/≥98%), with invalid test rate ≤5% where applicable. Detailed sample‑size tables (95% CI; 5% precision) and cross‑reactivity panels are provided, plus standardized report formats.
Ethical guidance exempts use of irreversibly de‑identified leftovers (with self‑declaration). The document aims to accelerate market access for high‑quality diagnostics and support global competitiveness
Applicable For: Importer & Manufacturer
Reference Number: File No. ICMR-CDSCO/IVD/2023-Part(2)
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