CDSCO issued a notification regarding inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO

Jan 03, 2025 | by TeamLease RegTech Legal Research Team

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Industry Specific ComplianceThe Central Drugs Standard Control Organisation (CDSCO) on January 01, 2025, issued a notification regarding inviting comments on standard IVD evaluation protocols drafted by ICMR and CDSCO.

The following has been stated: -

•ICMR and CDSCO have drafted standard evaluation protocols for In-Vitro Diagnostics (IVDs) to assess their quality and performance. 

•The protocols, covering various tests for Chikungunya, Dengue, and Zika virus, are open for public comment until February 15, 2025. 

•Stakeholders are encouraged to submit feedback via email in the provided format. Finalized protocols will be issued after reviewing the comments.

The detailed notification is given in the document below.

[Notification No. ICMR-CDSCO/IVD/GD/PROTOCOLS/01/2024]


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