The Indian Council of Medical Research and Central Drugs Standard Control Organization on July 16, 2026, invited comments on standard IVD evaluation protocols drafted by ICMR and CDSCO.
ICMR and CDSCO have jointly developed standard performance evaluation protocols for licensing In-Vitro Diagnostics (IVDs) under the Medical Devices Rules 2017, aimed at helping manufacturers and testing labs assess IVD quality and performance. Two draft protocols have been finalized so far: one for Scrub Typhus IgM ELISA and one for Scrub Typhus IgM RDT.
These drafts are now open for public comment, with stakeholders asked to submit feedback in the prescribed format to [email protected] by August 25, 2026. After this deadline, the protocols will have minimal scope for further changes, as comments will be reviewed and incorporated before ICMR and CDSCO grant final clearance.
[Notification No. ICMR-CDSCO/IVD/GD/PROTOCOLS/17/2026]
