Home› India› Ministry of Health and Family Welfare› Revised Guidance list of Laboratories on Performance Evluati...
Date: 2020-02-24 Category: Not Applicable State: Union Government Country: India

Revised Guidance list of Laboratories on Performance Evluation of IVDm (dated-24/02/2020)

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • The gazette provides guidance on the performance evaluation of In-vitro Diagnostic Medical Devices (IVDs) as per the Medical Devices Rules 2017.
  • It specifies that manufacturers must submit a performance evaluation report for their IVDs.
  • The State Licensing Authority (SLA) for Class B IVDs and the Central Licence Authority (CLA) for Class B, Class C, and Class D IVDs may require a performance evaluation report from designated laboratories.
  • The gazette lists specific laboratories that can conduct performance evaluations for various IVDs.
  • The guidance list of laboratories has been revised over time, with updates issued on October 16, 2019, and February 24, 2020, modifying the list of approved testing facilities for specific IVDs.

Key Changes

  • The notification dated August 7, 2018, lists 17 categories of reagents/kits for detection of various diseases and conditions for which performance evaluation is required.
  • The notification dated August 7, 2018, includes Glucose Test Strip and Fully Automated Analyser Based Glucose Reagent as a category for which performance evaluation is required.
  • The notification dated October 16, 2019, consolidates HIV, HBV, and HCV testing into a single category.
  • The notification dated October 16, 2019, removes the specific mention of life-threatening infections/agents and congenital disorders, instead deferring to any Central Government or State Government Laboratory of any hospital or of any institute.
  • The February 24, 2020 revision includes a revised list of laboratories to be considered for conducting performance evaluation of In-Vitro Diagnostics.
  • The February 24, 2020 revision includes seven ICMR institutes.
  • The October 16, 2019 revision includes nine new testing lab details.
  • The October 16, 2019 revision excludes three testing lab details.

Impact Analysis

Manufacturers of IVDs

  • Action Item: Review the list of designated laboratories and establish relationships with those relevant to your product portfolio.

Testing Laboratories

  • Action Item: Prepare for increased testing volumes and ensure adequate resources are available.

State Licensing Authority (SLA) / Central Licence Authority (CLA)

  • Action Item: Develop a system for tracking and verifying performance evaluation reports.

Hospitals and Healthcare Providers

  • Action Item: Ensure that the IVDs used in your facility have undergone the required performance evaluation.

Key Entities Referenced

Medical Devices Rules 2017: The regulatory framework governing medical devices in India. State Licensing Authority (SLA): The authority responsible for licensing Class A and Class B medical devices. Central Licence Authority (CLA): The authority responsible for licensing Class C and Class D medical devices. National Accreditation Board for Testing and Calibration Laboratories (NABL): Accreditation body for testing and calibration laboratories. National Accreditation Board for Hospitals and Healthcare Providers (NABH): Accreditation body for hospitals and healthcare providers. ICMR (Indian Council of Medical Research): Indian Council of Medical Research
Official Source Record View Original Source →
See Full Document Text
Dated:- 07-Aug-2018 Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices As per the proviso of Clause (h), Paragraph (ii), part II of Fourth Schedule of Medical Devices Rules 2017, where in, it is stated that “In case of in-vitro diagnostic medical devices, performance evaluation report by the manufacturer shall be submitted by the applicant. Provided that when the State Licensing Authority specifically requires for Class B or the Central Licence Authority for Class B, Class C and Class D in-vitro diagnostic medical devices, as the case may be, applicant shall submit the report issued by the central medical devices testing laboratory or a medical device testing laboratory registered under rule 83 or by any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers or by any Central Government or State Government Laboratory of any hospital or of any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority” In this regard, SLA/ CLA may require the Performance Evaluation Report for the following In-vitro Diagnostics from such laboratories, vide above proviso. I n-vitro Diagnostic Medical Devices intended for :- 1. HIV, 2. HBV, 3. HCV, 4. Blood Grouping reagent, 5. Cancer, 6. Tuberculosis, 7. Malaria, 8. Dengue, 9. Chikungunia, 10. Syphlis, 11. Typhoid, 12. Influenza, 13. ToRCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus) 14. Chlamydia 15. Pneumonia, 16. Methicilline-Resistant Staphylococcus Aureus, 17. Entero virus, 18. Marker for congenital disorder e.g. Screen test for Down’s Syndrome 19. Sexually transmitted agent i.e. Treponema pallidum, Neisseria gonorrhoeae, Human Papilloma Virus, Herpes Virus 20. Other life threatening Infections / agent. Page 1 of 12Dated 24 Feb 2020 Revised guidance list of Laboratories to be considered for conducting Performance Evaluation of In-Vitro Diagnostics is as following Sr. Category of In vitro Name of Testing facility No. Diagnostics Medical Devices 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) ICMR-National AIDS Research Institute. (ICMR). 73, 'G'- Block MIDC Bhosari, Pune - 411026, Maharashtra , India 3) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 1. In-Vitro Diagnostics for HIV 4) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 6) ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 2. 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) ICMR-National AIDS Research Institute. (ICMR). 73, 'G'- Block MIDC Bhosari, Pune - 411026, Maharashtra , India 3) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India In-Vitro Diagnostics for 4) Christian Medical College & Hospital, Ida Scudder Road, HBV Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 6) ICMR- National Institute of Immunohaematology, 13th floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, Maharashtra 400012 3. 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) ICMR-National AIDS Research Institute. (ICMR). 73, 'G'- Block MIDC Bhosari, Pune - 411026, Maharashtra , India 3) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India In-Vitro Diagnostics for 4) Christian Medical College & Hospital, Ida Scudder Road, HCV Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 6) ICMR- National Institute of Eipidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 Page 2 of 121) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) Indian Red Cross Society, 1, Red Cross Road, New Delhi In vitro Diagnostic 3) ICMR- National Institute of Pathology, Sadarjang Hospital Medical Devices for Campus, Ansari Nagar West, New Delhi, Delhi 110029 4. Blood Grouping or 4) ICMR- National Institute of Immunohaematology, 13th floor, Tissue Typing New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, Maharashtra 400012 5) ICMR-Regional Medical Research Centre, N.E. Region, P.O.- Lahowal, Dibrugarh - 786 010 Assam, INDIA 1) ICMR- Institute of Cytology and Preventive Oncology (ICPO), I- 7, Sector - 39, Noida 201301 Uttar Pradesh, INDIA 2) ICMR- National Institute of Pathology, ICMR- National Institute of Pathology, Sadarjang Hospital Campus, Ansari Nagar West, New Delhi, Delhi 110029 3) ICMR-Regional Medical Research Centre, N.E. Region, P.O.- Reagents/ Kits for Lahowal, Dibrugarh - 786 010 Assam, INDIA 5. detection of Cancer 4) Medical College and Hospital (Department of Oncology/ Medical Oncology), 88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073 5) Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India 6) Tata Medical Center, 14 MAR (E-W), New Town, Rajarhat, Kolkata 700156 1) ICMR- National Institute for Research in Tuberculosis, Mayor Sathiyamoorthy Road, Chetpet, Chennai – 600 031, India 2) ICMR- National Jalma Institute of Leprosy and other mycobacterial diseases P.O BOX 101, Dr. M. Miyazaki Marg, Tajganj, Agra – 282001 3) ICMR-Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha 751023 4) National Institute of Tuberculosis & Respiratory Diseases, Sri Reagents/ Kits for Aurobindo Marg, Near Qutub Minar New Delhi- 110030 6. Detection of 5) National Tuberculosis Institute, 8, Bellary Road, Bangalore 560 Tuberculosis (TB) 003, India, 6) Rajan Babu T.B. Hospital, Kingsway Camp, GTB Nagar, Delhi 110009 7) Shantabai Devarao Shivaram Tuberculosis Research Centre & Rajiv Gandhi Institute of Chest Diseases, Someshwara Nagar 1st Main Road, Dharmaram College Post, Bangalore - 560 029 8) Dept. of Microbiology, The Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012 1) ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India) 2) ICMR- National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. Reagents/ Kits for 7. 3) ICMR- Vector Control Research Centre, Medical Complex, Detection of Malaria VCRC Road, Indra Nagar, Priyadarshini Nagar, Puducherry, 605006 4) All India Institute of Medical Sciences, Division of Clinical Microbiology & Molecular Medicine, New Delhi-110029 Page 3 of 121) ICMR- Vector Control Research Centre, Medical Complex, VCRC Road, Indra Nagar, Priyadarshini Nagar, Puducherry, 605006 2) ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India) 3) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 Reagents/ Kits for Detection 4) National Institute of Cholera and Enteric Diseases,P- 33, 8. of Dengue C.I.T. Road, Scheme XM, Beleghata, Kolkata 700010 5) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 6) King Institute, Guindy Flyover, Guindy Institutional Area, SIDCO Industrial Estate, Guindy, Chennai, Tamil Nadu 600032 7) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 Reagents/ Kits for Detection 1) ICMR-National Institute for Research in Trible Health, of Chikungunya Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. 2) ICMR- National Institute of Cholera and Enteric Diseases,P- 33, C.I.T. Road, Scheme XM, Beleghata, Kolkata 700010 9. 3) ICMR- Vector Control Research Centre, Medical Complex, VCRC Road, Indra Nagar, Priyadarshini Nagar, Puducherry, 605006 4) ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India) 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) ICMR-National AIDS Research Institute. (ICMR). 73, 'G'- Block MIDC Bhosari, Pune - 411026, Maharashtra , India (Including HIV, HBV, HCV & Syphilis in single kit) 3) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Reagents/ Kits for Detection Road, Post Box No. 11 Pune 411001, India (Including HIV, 10. of Treponema pallidum HBV, HCV & Syphilis in single kit) (Syphilis) 4) ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 5) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 1) ICMR-National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. Reagents/ Kits for Detection 2) ICMR-National Institute of Cholera and Enteric Diseases, P- 11. of Typhoid 33 C.I.T. Road, Kolkata-700010 3) Dept. of Microbiology, The Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012 Page 4 of 121) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 2) ICMR-Regional Medical Research Centre, N.E. Region, P.O.- Lahowal, Dibrugarh - 786 010 Assam, INDIA 2) Division Bacteriology, ICMR-National Institute of Cholera Reagents/ Kits for Detection 12. and Enteric Diseases, P-33 C.I.T. Road, Kolkata-700010 of Influenza 3) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 4) Sawai Man Singh Medical College, Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004 1) Division Bacteriology, ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Kolkata-700010 Reagents/ Kits for Detection 13. 2) ICMR-National Institute of Epidemiology, R 127, 3rd of Toxoplasma Gondii Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 1) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 2) ICMR- National Institute for Research in Reproductive Reagents/ Kits for Detection Health, Jehangir Merwanji Street, Parel, Mumbai, 14. of Rubella Virus & Maharashtra 400012 Cytomegalovirus 3) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 1) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Reagents/ Kits for Detection 15. Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 of Pneumonia 2) ICMR-National Institute for Research in Tuberculosis, Mayor Sathiyamoorthy Road, Chetpet, Chennai – 600 031, India 1) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Reagents/ Kits for Detection Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 16. of Methicilline-Resistant 2) ICMR-National Institute of Cholera and Enteric Diseases, P- Staphylococcus Aureus 33 C.I.T. Road, Kolkata-700010 3) Dept. of microbiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha 751019 1) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Regents/Kits for detection of Road, Post Box No. 11 Pune 411001, India 17. Entero Virus (A/B) 2) ICMR-National Institute of Cholera and Enteric Diseases, P- 33 C.I.T. Road, Kolkata-700010 1) ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 2) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Reagents/ Kits for Detection Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 18. of markers for Congenital 3) Division of Genetics, Dept. of Paediatrics’, All India Institute disorders of Medical Sciences, New Delhi 4) Division of Genetics, Dept. of Paediatrics’, Maulana Azad Medical College, New Delhi 5) Any Central Government or State Government Laboratory of any hospital or of any institute. Page 5 of 121) ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 Reagents/ Kits for Detection 19. 2) ICMR-Regional Medical Research Centre, NALCO Nagar, of Neisseria Gonorrhoeae Chandrasekharpur, Bhubaneswar, Odisha 751023 3) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 1) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 2) ICMR- National Institute for Research in Reproductive Reagents/ Kits for Detection Health, Jehangir Merwanji Street, Parel, Mumbai, 20. and typing of Human Maharashtra 400012 Papilloma Virus infection 3) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 Reagents/ Kits for Detection Any Central Government or State Government Laboratory of 21. of autoimmune Disorders any hospital or of any institute. Reagents/ Kits for human Any Central Government or State Government Laboratory of 22. Genetic testing any hospital or of any institute.  Seven ICMR institute included. *** . Page 6 of 12Dated 16 Oct 2019 Revised guidance list of Laboratories to be considered for conducting Performance Evaluation of In-Vitro Diagnostics is as following Sr. Category of In vitro Name of Testing facility No. Diagnostics Medical Devices 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) National AIDS Research Institute. (ICMR). 73, 'G'-Block In-Vitro Diagnostics for MIDC Bhosari, Pune - 411026, Maharashtra , India human Immunodeficiency 3) National Institute of Virology, 20/ A, Dr. Ambedkar Road, 1. virus, Hepatitis B Surface Post Box No. 11 Pune 411001, India Antigen and Hepatitis C 4) Christian Medical College & Hospital, Ida Scudder Road, Virus Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 In vitro Diagnostic Medical 1) National Institute of Biologicals, Plot No. A-32, Sector-62, 2. Devices for Blood Grouping Institutional Area, Noida, Uttar Pradesh 201309 or Tissue Typing 2) Indian Red Cross Society, 1, Red Cross Road, New Delhi 3. In vitro Diagnostic Medical 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Devices for Blood Grouping Institutional Area, Noida, Uttar Pradesh 201309 or Tissue Typing 1) Institute of Cytology and Preventive Oncology (ICPO), I-7, Sector - 39, Noida 201301 Uttar Pradesh, INDIA 2) Chittaranjan National Cancer Institute, 37, S.P.Mukherjee Road,Kolkata-700 026.INDIA 3) Tata Memorial Hospital, Dr. E Borges Road, Parel, Reagents/ Kits for 4. Mumbai - 400 012 India detection of Cancer 4) Tata Medical Center, 14 MAR (E-W), New Town, Rajarhat, Kolkata 700156 5) Medical College and Hospital (Department of Oncology/ Medical Oncology), 88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073 1) National Institute for Research in Tuberculosis, Mayor Sathiyamoorthy Road, Chetpet, Chennai – 600 031, INDIA 2) National Tuberculosis Institute, 8, Bellary Road, Bangalore 560 003, India, 3) Dept. of Microbiology, The Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012 4) National Institute of Tuberculosis & Respiratory Diseases, Reagents/ Kits for Detection 5. Sri Aurobindo Marg,Near Qutub Minar New Delhi- 110030 of Tuberculosis (TB) 5) National Jalma Institute of Leprosy and other mycobacterial diseases P.O BOX 101, Dr. M. Miyazaki Marg, Tajganj, Agra – 282001 6) Rajan Babu T.B. Hospital, Kingsway Camp, GTB Nagar, Delhi 110009 7) Shantabai Devarao Shivaram Tuberculosis Research Centre & Rajiv Gandhi Institute of Chest Diseases, Someshwara nagar 1st Main Road, Dharmaram College Post, Bangalore - 560 029 Page 7 of 128) National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. 1) National Institute of Malaria Research (ICMR), Sector 8, Dwarka, Delhi-110077 (India) 2) National Institute for Research in Trible Health, Nagpur Reagents/ Kits for Detection Road, Near NSCB Medical College Jabalpur, Madhya 6. of Malaria Pradesh, 482003. 3) All India Institute of Medical Sciences, Division of Clinical Microbiology & Molecular Medicine, New Delhi-110029 1) National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 2) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 3) National Institute of Biologicals, Plot No. A-32, Sector-62, Reagents/ Kits for Detection Institutional Area, Noida, Uttar Pradesh 201309 7. of Dengue 4) National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. 5) National Institute of Cholera and Enteric Diseases,P- 33, C.I.T. Road, Scheme XM, Beleghata, Kolkata 700010 6) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 Reagents/ Kits for Detection 1) National Institute for Research in Trible Health, Nagpur of Chikungunya Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. 8. 2) National Institute of Cholera and Enteric Diseases,P- 33, C.I.T. Road, Scheme XM, Beleghata, Kolkata 700010 3) National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Reagents/ Kits for Detection Institutional Area, Noida, Uttar Pradesh 201309 9. of Treponema pallidum 2) Christian Medical College & Hospital, Ida Scudder Road, (Syphilis) Vellore, Tamil Nadu 632004 1) Dept. of Microbiology, The Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, Reagents/ Kits for Detection 10. Chandigarh, 160012 of Typhoid 2) Division Bacteriology, ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Kolkata-700010 1) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 2) Sawai Man Singh Medical College, Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan Reagents/ Kits for Detection 11. 302004 of Influenza 3) National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 4) Division Bacteriology, ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Kolkata-700010 Reagents/ Kits for Detection Any Central Government or State Government Laboratory 12. of ToRCH of any hospital or of any institute. Page 8 of 121) Division of Genetics, Dept. of Paediatrics’, Maulana Azad Medical College, New Delhi Reagents/ Kits for Detection 2) Division of Genetics, Dept. of Paediatrics’, All India 13. o f markers for Congenital Institute of Medical Sciences, New Delhi disorders 3) Any Central Government or State Government Laboratory of any hospital or of any institute. Reagents/ Kits for Detection Any Central Government or State Government Laboratory 14. o f sexually transmitted of any hospital or of any institute. Disease Reagents/ Kits for Detection Any Central Government or State Government Laboratory 15. a nd typing of Human of any hospital or of any institute. Papilloma Virus infection Reagents/ Kits for Detection Any Central Government or State Government Laboratory 16. of autoimmune Disorders of any hospital or of any institute. Reagents/ Kits for human Any Central Government or State Government Laboratory 17. Genetic testing of any hospital or of any institute.  9 New testing lab details included.  3 testing lab details excluded. *** Page 9 of 12Dated 07 Aug 2018 Guidance list of Laboratories to be considered for conducting Performance Evaluation of In-Vitro Diagnostics is as following Sr. Category of In vitro Name of Testing facility No. Diagnostics Medical Devices 1. In-Vitro Diagnostics for 1) National Institute of Biologicals, Plot No. A-32, human Immunodeficiency Sector-62, Institutional Area, Noida, Uttar Pradesh virus, Hepatitis B Surface 201309 Antigen and Hepatitis C 2) National AIDS Research Institute. (ICMR). 73, 'G'- Virus Block MIDC Bhosari, Pune - 411026, Maharashtra , India 3) National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 4) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 2. In vitro Diagnostic Medical 1) National Institute of Biologicals, Plot No. A-32, Devices for Blood Sector-62, Institutional Area, Noida, Uttar Pradesh Grouping or Tissue Typing 201309 2) Indian Red Cross Society, 1, Red Cross Road, New Delhi` 3. Glucose Test Strip, Fully 1) National Institute of Biologicals, Plot No. A-32, Automated Analyser Sector-62, Institutional Area, Noida, Uttar Pradesh Based Glucose Reagent 201309 4. Reagents/ Kits for 1) Institute of Cytology and Preventive Oncology detection of Cancer (ICPO), I-7, Sector - 39, Noida 201301 Uttar Pradesh, INDIA 2) Chittaranjan National Cancer Institute, 37, S.P.Mukherjee Road,Kolkata-700 026.INDIA 3) Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India 4) Tata Medical Center, 14 MAR (E-W), New Town, Rajarhat, Kolkata 700156 5) Medical College and Hospital (Department of Oncology/ Medical Oncology), 88, College St, Calcutta Medical College, College Square, Kolkata, West Bengal 700073 5. Reagents/ Kits for 1) National Institute for Research in Tuberculosis, Detection of Tuberculosis Mayor Sathiyamoorthy Road, Chetpet, Chennai - 600 (TB) 031, INDIA 2) National Tuberculosis Institute „AVALON‟ No.8, Page 10 of 12Bellary Road, Bangalore 560 003, India, 3) Dept. of Microbiology, The Postgraduate Institute of Medical Education and Research, Chandigarh, , Sector 12, Chandigarh, 160012 4) LRS Institute of TB and Respiratory Diseases, Sri Aurobindo Marg,Near Qutub Minar New Delhi- 110030 5) National Jalma Institute of Leprosy and other mycobacterial diseases P.O BOX 101, Dr. M. Miyazaki Marg, Tajganj, Agra – 282001 6) Shantabai Devarao Shivaram Tuberculosis Research Centre & Rajiv Gandhi Institute of Chest Diseases, Someshwara nagar 1st Main Road, Dharmaram College Post, Bangalore - 560 029 7) Rajan Babu T.B. Hospital, Kingsway Camp, GTB Nagar, Delhi 110009 6. Reagents/ Kits for 1) National Institute of Malaria Research (ICMR), Sector Detection of Malaria 8, Dwarka, Delhi-110077 (India) 2) National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. 3) National Institute of Cholera and Enteric Diseases,P- 33, C.I.T. Road, Scheme XM, Beleghata, Kolkata 700 010 4) All India Institute of Medical Sciences, Division of Clinical Microbiology & Molecular Medicine New Delhi-110029 5) National Institute of Communicable Diseases (NICD) 22, Sham Nath Marg, New Delhi 7. Reagents/ Kits for 1) National Centre for Disease Control 22, Sham Nath Detection of Dengue Marg, New Delhi-110 054, India 2) National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 3) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 4) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 5) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 Any Central Government or State Government 8. Reagents/ Kits for Detection of Chikungunya Laboratory of any hospital or of any institute. Page 11 of 129. Reagents/ Kits for 1) National Institute of Biologicals, Plot No. A-32, Detection of Treponema Sector-62, Institutional Area, Noida, Uttar Pradesh pallidum (Syphilis 201309 2) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 10. Reagents/ Kits for 1) Dept. of Microbiology, The Postgraduate Institute of Detection of Typhoid Medical Education and Research, Chandigarh, , Sector 12, Chandigarh, 160012 2) Division Bacteriology, ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Kolkata-700010 11. Reagents/ Kits for 1) Department of Clinical Virology, Institute of Liver & Detection of Influenza Biliary Sciences, D-1, Vasant Kunj New Delhi-70 2) National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 3) Division Bacteriology, ICMR-Na`tional Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Kolkata-700010 12. Reagents/ Kits for Any Central Government or State Government Detection of ToRCH Laboratory of any hospital or of any institute 13. Reagents/ Kits for Any Central Government or State Government Detection of markers for Laboratory of any hospital or of any institute Congenital disorders 14. Reagents/ Kits for Any Central Government or State Government Detection of sexually Laboratory of any hospital or of any institute transmitted Disease 15. Reagents/ Kits for Any Central Government or State Government Detection and typing of Laboratory of any hospital or of any institute Human Papilloma Virus infection 16. Reagents/ Kits for Any Central Government or State Government Detection of autoimmune Laboratory of any hospital or of any institute disorders 17. Reagents/ Kits for human Any Central Government or State Government Genetic testing Laboratory of any hospital or of any institute Further the services of other laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories or by any hospital accredited, by National Accreditation Board for Hospitals and Healthcare Providers etc. can also be availed subsequently as per MDR-2017 Rules. *** Page 12 of 12

Continue your research

Related Documents from Ministry of Health and Family Welfare