The Central Drugs Standard Control Organization (CDSCO) has recently released an updated and expanded list of laboratories approved for performance evaluation of in vitro diagnostic (IVD) medical devices in India. This update is critical for medical device manufacturers, importers, and startups planning to launch IVD products in the Indian market, as performance evaluation is a key component of the regulatory approval process under the Medical Device Rules, 2017.
The updated list categorizes testing labs based on the specific diseases or conditions the IVD kits are intended to detect. This move is expected to improve access to reliable performance testing services across the country, ensuring faster time to market for new diagnostic devices.
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Breakdown of CDSCO-Approved Laboratories for IVD Performance Evaluation
As per the latest update, CDSCO has listed a number of laboratories with specific scopes for evaluating IVD reagents and diagnostic kits. Here’s the detailed breakdown:
- HIV Detection: 13 laboratories approved
- Hepatitis B (HBV): 13 laboratories
- Hepatitis C (HCV): 12 laboratories
- Blood Grouping / Tissue Typing: 10 laboratories
- Cancer Biomarker Detection: 9 laboratories
- Tuberculosis (TB): 14 laboratories
- Malaria: 7 laboratories
- Dengue: 18 laboratories
- Chikungunya: 13 laboratories
- Treponema pallidum (Syphilis): 10 laboratories
- Typhoid: 7 laboratories
- Influenza: 13 laboratories
- Toxoplasma Gondii: 6 laboratories
- Rubella Virus & Cytomegalovirus (CMV): 6 laboratories
- Pneumonia Pathogens: 5 laboratories
- Methicillin-Resistant Staphylococcus Aureus (MRSA): 7 laboratories
- Enterovirus A/B: 5 laboratories
- Neisseria Gonorrhoeae: 9 laboratories
- Human Papilloma Virus (HPV) Typing: 6 laboratories
- Sickle Cell Detection: 5 laboratories
This extensive list allows manufacturers to select laboratories based on the type of diagnostic kit they are developing, which helps streamline the regulatory approval workflow.
COVID-19 IVD Kits: Special Focus and Updated Lab List
In response to a fresh wave of COVID-19 infections in the country, CDSCO has also updated the list of approved laboratories for the evaluation of SARS-CoV-2 diagnostic kits, including RT-PCR and RT-LAMP technologies.
The approved institutions for COVID-19 IVD evaluation include:
National Institute of Biologicals (NIB), Uttar Pradesh – Authorized for RT-PCR and RT-LAMP evaluation
Virus Research and Diagnostic Laboratories (VRDLs) located in:
- New Delhi
- Assam
- Telangana
- Puducherry
- Karnataka (2 labs)
These facilities are well-equipped to carry out performance evaluation of COVID-19 detection kits, especially RT-PCR kits, which are the gold standard for COVID diagnostics.
Need help getting your IVD device CDSCO-approved?
Role of Operon Strategist
Understanding which labs to approach is just one part of the regulatory puzzle. Successfully navigating the CDSCO regulatory framework for IVD medical devices requires thorough preparation, documentation, and coordination. This is where Operon Strategist plays a vital role.
As a leading medical device regulatory consultant, Operon Strategist offers end-to-end solutions for IVD manufacturers, including:
- Regulatory pathway guidance for IVD products
- Preparation and review of technical documentation
- Assistance with performance evaluation coordination
- Support with CDSCO registration and post-approval compliance
- Turnkey consulting for IVD startups and manufacturers
Whether you’re a domestic manufacturer or an international firm planning to enter the Indian market, Operon Strategist provides customized consulting to accelerate your regulatory approval process, minimize compliance risks, and ensure smooth product launch.
With CDSCO tightening compliance and expanding its approved lab network, manufacturers need to act quickly and strategically. Working with a professional regulatory partner like Operon Strategist ensures that your IVD kits are tested at the right laboratories and meet all regulatory expectations.
Need Help with IVD Compliance in India?
Connect with our experts at Operon Strategist for complete regulatory support and performance evaluation guidance for your IVD medical devices.
