New Delhi, January 6, 2025 – The Central Drugs Standard Control Organisation (CDSCO), in collaboration with the Indian Council of Medical Research (ICMR), has issued draft standard evaluation protocols for licensing in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017. These protocols aim to ensure quality and performance consistency of IVD kits in India.
Key Highlights of the Draft Protocols
Draft Protocols for 14 Tests
The draft covers performance and field evaluation protocols for various tests, including Chikungunya and Dengue diagnostics, as well as Zika virus real-time PCR.
Public Consultation Period
Stakeholders are invited to submit feedback by February 15, 2025. After this period, the protocols will be finalized with minimal changes.
Objective of the Guidelines
These guidelines are designed to standardize performance evaluations and ensure that diagnostic kits meet India’s quality and safety standards.
No Repeat Testing for NSQ Kits
Kits found to be Not of Standard Quality (NSQ) will not be eligible for re-testing unless valid proof of changes in composition is provided.
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Strengthening Medical Device Regulations
This initiative is part of the broader regulatory framework under MDR, 2017, to enhance the safety and reliability of medical devices in India.
To Ensure Your IVD Kits Comply With the Latest CDSCO and ICMR Standards for Smooth Licensing
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