Performance Evaluation of IVDs

CDSCO updated list of laboratories to conduct Performance evaluation of IVDs

This CDSCO notification, dated June 4, 2025, provides an updated list of laboratories approved for conducting performance evaluations of In-Vitro Diagnostic (IVD) Medical Devices.

The notification covers IVDs for the detection of various conditions, including:

• HIV
• HBV (Hepatitis B Virus)
• HCV (Hepatitis C Virus)
• Blood Grouping or Tissue Typing
• Cancer
• Tuberculosis (TB)
• Malaria
• Dengue
• Chikungunya
• Treponema pallidum (Syphilis)
• Typhoid
• Influenza
• Toxoplasma Gondii
• Rubella Virus & Cytomegalovirus
• Pneumonia
• Methicilline-Resistant Staphylococcus aureus
• Entero Virus (A/B)
• Markers for Congenital disorders
• Neisseria Gonorrhoeae
• Human Papilloma Virus infection (detection and typing)
• Sickle Cell
• SARS-CoV-2

The listed testing facilities primarily include government-affiliated institutions across India, encompassing:

• National Institutes: Such as National Institute of Biologicals (Noida) , ICMR-National AIDS Research Institute (Pune) , ICMR-National Institute of Virology (Pune) , ICMR-National Institute for Research in Reproductive Health (Mumbai) , ICMR-National Institute of Cholera and Enteric Diseases (Kolkata) , ICMR-National Institute of Immunohaematology (Mumbai) , ICMR- National Institute of Epidemiology (Chennai) , ICMR- National Institute of Pathology (New Delhi) , ICMR- Institute of Cytology and Preventive Oncology (Noida) , ICMR-Regional Medical Research Centre (Dibrugarh) , ICMR- National Institute for Research in Tuberculosis (Chennai) , ICMR- National Jalma Institute of Leprosy and other mycobacterial diseases (Agra) , ICMR-Regional Medical Research Centre (Bhubaneswar) , National Institute of Tuberculosis & Respiratory Diseases (New Delhi) , National Tuberculosis Institute (Bangalore), Rajan Babu T.B. Hospital (Delhi) , ICMR- National Institute of Malaria Research (Delhi) , ICMR- National Institute for Research in Tribal Health (Jabalpur) , ICMR- Vector Control Research Centre (Puducherry) , National Centre for Disease Control (Delhi).
  
• All India Institutes of Medical Sciences (AIIMS): Locations include Bathinda , Raebareli , Bhubaneswar , New Delhi , Jodhpur , Patna. Many AIIMS facilities are also designated as Viral Research and Diagnostic Laboratories (VRDLs).
  
• Medical Colleges & Hospitals: Christian Medical College & Hospital (Vellore) , Department of Clinical Virology, Institute of Liver & Biliary Sciences (New Delhi) , Medical College and Hospital (Kolkata) , Tata Memorial Hospital (Mumbai) , Tata Medical Center (Kolkata) , Dept. of Microbiology, The Postgraduate Institute of Medical Education and Research (Chandigarh) , Osmania Medical College (Hyderabad) , Mysore Medical College and Research Institute (Mysore) , BMCRI Bengaluru , Sawai Man Singh Medical College (Jaipur) , Maulana Azad Medical College (New Delhi).
  
• Other Research Centers/Institutes: Rajiv Gandhi Centre for Biotechnology (Thiruvananthapuram) , National Institute of Mental Health and Neurosciences (Bengaluru) , Department of Biological Control, King Institute of Preventive Medicine & Research (Chennai) , Shantabai Devarao Shivaram Tuberculosis Research Centre & Rajiv Gandhi Institute of Chest Diseases (Bangalore).

The majority of these facilities are government-affiliated institutions or departments within government medical colleges and hospitals. Some VRDLs specify the product technologies they are equipped for, such as RT-PCR, RAPID, and ELISA.

The notification also mentions that any Central or State Government Laboratory of any hospital or institute can be considered for detection of markers for congenital disorders

Source :
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI3OTc=