Date: 2022-05-05 Category: Not Applicable State: Union Government Country: India

List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

The gazette notification lists laboratories authorized to conduct performance evaluations of In-Vitro Diagnostic (IVD) medical devices, specifically analyzers, instruments, and software.
The listed laboratories are primarily ICMR (Indian Council of Medical Research) institutions.
The notification specifies the types of diagnostic technologies each laboratory is equipped to evaluate for various diseases.

Key Changes

The notification provides a list of specific laboratories and the types of In-Vitro Diagnostic (IVD) medical devices they are authorized to evaluate.
ICMR-National AIDS Research Institute (Pune) is listed for RDT (Rapid Diagnostic Tests) for HIV, HBV, HCV and Treponema pallidum (Syphilis).
ICMR-National Institute of Cholera and Enteric Diseases (Kolkata) is listed for a wide range of diagnostic technologies including EIA, CLIA, ECLIA, Western Blot, Viral Lysate, Molecular Diagnostic technologies for HIV, HBV, HCV, Dengue, Chikungunya, Typhoid and Methicilline-Resistant Staphylococcus Aureus.
National Reference Laboratory for Tuberculosis (Bhopal) is listed for Molecular Diagnostic technologies, Culture Based, ZN Microscopy, FM Microscopy for Tuberculosis (TB).
ICMR-National Institute of Virology (Pune) is listed for Molecular Diagnostic technologies for Influenza.

Impact Analysis

IVD Manufacturers

Action Item: Review the list of laboratories and their capabilities to determine the appropriate testing facility for your IVD products.

Testing Laboratories

Action Item: Prepare for increased demand for performance evaluation services and ensure adequate resources are available.

Regulatory Bodies

Action Item: Ensure that the listed laboratories are regularly audited to maintain quality standards and compliance.

Healthcare Providers and Patients

Action Item: Healthcare providers can have increased confidence in the accuracy of IVD tests that have been evaluated by these listed laboratories.

Key Entities Referenced

ICMR-National AIDS Research Institute: A research institute under the Indian Council of Medical Research (ICMR) located in Pune, Maharashtra, specializing in AIDS research and diagnostics. ICMR-National Institute of Cholera and Enteric Diseases: A research institute under the Indian Council of Medical Research (ICMR) located in Kolkata, specializing in cholera and enteric diseases research and diagnostics. National Reference Laboratory for Tuberculosis: A laboratory under the Department of Microbiology, Bhopal Memorial Hospital & Research Centre, under ICMR, DHR, specializing in Tuberculosis diagnostics. ICMR-National Institute of Virology: A research institute under the Indian Council of Medical Research (ICMR) located in Pune, specializing in virology research and diagnostics. In-Vitro Diagnostics Medical Device (IVD): Medical devices used for examining specimens, such as blood, tissue, and urine, that have been taken from the human body.

Official Source Record View Original Source →

See Full Document Text

                Dated: 05 May 2022
List of Laboratories for conducting Performance Evaluation of
In-Vitro Diagnostics Medical Device (Analyzer, Instrument and software)
Sr. Category of In vitro Particular of Name and address of Testing
No. Diagnostics technology laboratory
Analyzer, Instrument
and software
1. Analyzer, Instrument RDT (Rapid Diagnostic ICMR-National AIDS Research
and software for Tests) Institute, Plot No. 73, G-Block, MIDC,
detection of HIV Bhosari, Pune-26, Maharashtra
ICMR-National Institute of Cholera and
Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
EIA (Enzyme ICMR-National Institute of Cholera and
Immunoassays)/ CLIA Enteric Diseases, P-33, C.I.T Road,
(chemiluminescence Scheme-XM, Beliaghata. Kolkata-
immunoassays)/ 700010
ECLIA (electro
chemiluminescence
immunoassays)
Western Blot/ Viral ICMR-National Institute of Cholera and
Lysate Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
Molecular Diagnostic ICMR-National Institute of Cholera and
technologies (PCR, RT- Enteric Diseases, P-33, C.I.T Road,
PCR, etc.) Scheme-XM, Beliaghata. Kolkata-
700010
2. Analyzer, Instrument RDT ICMR-National AIDS Research
and software for Institute, Plot No. 73, G-Block, MIDC,
detection of HBV Bhosari, Pune-26, Maharashtra
ICMR-National Institute of Cholera and
Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
EIA / CLIA/ ECLIA ICMR-National Institute of Cholera and
Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
3. Analyzer, Instrument RDT ICMR-National AIDS Research
and software for Institute, Plot No. 73, G-Block, MIDC,
detection of HCV Bhosari, Pune-26, Maharashtra
ICMR-National Institute of Cholera and
Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
EIA / CLIA/ ECLIA ICMR-National Institute of Cholera and
Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
Page 1 of 3Sr. Category of In vitro Particular of Name and address of Testing
No. Diagnostics technology laboratory
Analyzer, Instrument
and software
4. Analyzer, Instrument Molecular Diagnostic National Reference Laboratory for
and software for technologies (PCR, RT- Tuberculosis, department of
detection of PCR, etc.) Microbiology, Bhopal Memorial Hospital
Tuberculosis (TB) & Research Centre, under ICMR, DHR,
Raisen Bypass Road, Near Karond
Chouraha, Bhopal - 462038
Culture Based National Reference Laboratory for
Tuberculosis, department of
Microbiology, Bhopal Memorial Hospital
& Research Centre, under ICMR, DHR,
Raisen Bypass Road, Near Karond
Chouraha, Bhopal - 462038
ZN Microscopy, FM National Reference Laboratory for
Microscopy Tuberculosis, department of
Microbiology, Bhopal Memorial Hospital
& Research Centre, under ICMR, DHR,
Raisen Bypass Road, Near Karond
Chouraha, Bhopal - 462038
5. Analyzer, Instrument RDT ICMR-National Institute of Cholera and
and software for Enteric Diseases, P-33, C.I.T Road,
detection of Dengue Scheme-XM, Beliaghata. Kolkata-
700010
EIA / CLIA/ ECLIA ICMR-National Institute of Cholera and
Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
6. Analyzer, Instrument RDT ICMR-National Institute of Cholera and
and software for Enteric Diseases, P-33, C.I.T Road,
detection of Scheme-XM, Beliaghata. Kolkata-
Chikungunya, 700010
EIA / CLIA/ ECLIA ICMR-National Institute of Cholera and
Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
7. Analyzer, Instrument RDT ICMR-National AIDS Research
and software for Institute, Plot No. 73, G-Block, MIDC,
detection of Bhosari, Pune-26, Maharashtra
Treponema pallidum
(Syphilis)
8. Analyzer, Instrument Widal agglutination ICMR-National Institute of Cholera and
and software for assay test Enteric Diseases, P-33, C.I.T Road,
detection of Typhoid, Scheme-XM, Beliaghata. Kolkata-
700010
Culture based testing ICMR-National Institute of Cholera and
Enteric Diseases, P-33, C.I.T Road,
Scheme-XM, Beliaghata. Kolkata-
700010
Page 2 of 3Sr. Category of In vitro Particular of Name and address of Testing
No. Diagnostics technology laboratory
Analyzer, Instrument
and software
9. Analyzer, Instrument Molecular Diagnostic ICMR-National Institute Of Virology,
and software for technologies (PCR, RT- Pune, 20-A, Dr. Ambedkar Road,
detection of Influenza PCR, etc.) Pune-411001
10. Analyzer, Instrument Culture based testing ICMR-National Institute of Cholera and
and software for Enteric Diseases, P-33, C.I.T Road,
detection of Scheme-XM, Beliaghata. Kolkata-
Methicilline-Resistant 700010.
Staphylococcus
Aureus,
Page 3 of 3
            

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