The Ministry of Health and Family Welfare (MoHFW) on January 28, 2025, issued the notification regarding the Draft standard IVD evaluation protocol drafted by ICMR and CDSCO.
The following has been stated namely: -
• To facilitate the process Licensure of the detailed evaluation protocol for the performance evaluation of In-Vitro Diagnostics (IVDs) to evaluate their quality and performance, the Indian Council of Medical Research (ICMR) and CDSCO have come together to draft standard evaluation protocols for use by IVD manufacturers testing labs in India.
• The following are the requirements: -
o Supply of kits under evaluation (Along with batch/lot No. Expiry & required details). If the kit to be evaluated works in a closed system format, the manufacturer needs to supply the required equipment.
o Evaluation sites/laboratories (With required equipment)
o Reference test kits
o Characterised Evaluation panel
o Laboratory supplies
• Stakeholders are requested to provide their comments before March 15, 2025, at [email protected] as per the prescribed format.
[Notification No. ICMR-CDSCO/IVD/GD/PROTOCOLS/04/2024]
