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CDSCO Issues Guidelines On Performance Evaluation Of IVDs For Grant Of Manufacturing And Import Licenses

CDSCO Issues Guidelines On Performance Evaluation Of IVDs For Grant Of Manufacturing And Import Licenses


Mumbai, 14 Oct 2019:

 

The Central Drugs Standard Control Organisation (CDSCO) has issued guidelines on performance evaluation of In-Vitro Diagnostic (IVD) medical devices for grant of manufacturing and import licenses as per new Medical Device (MD) Rules, 2017 which is effective from January 1, 2018.

 

It has also issued reference list of laboratories in the country for conducting performance evaluation of IVDs. It has directed the notified laboratories to test and evaluate IVD medical devices and issue performance evaluation reports (PERs) for the purpose of grant of manufacturing and import licenses.

 

Import license is issued by CDSCO in India for an individual or industry having wholesale or manufacturing license for medical devices.

 

Name of the testing labs are National AIDS Research Institute, Pune, National Institute of Virology, Pune, Christian Medical College (CMC), Vellore, Tamil Nadu, Department of Clinical Virology, Institute of Liver and Biliary Sciences, New Delhi, Institute of Cytology and Preventive OncQogy (ICPO), Noida, Uttar Pradesh, Chittaranjan National Cancer Institute, Kolkata, Tata Memorial Hospital, Mumbai, Tata Medical Center, Kolkata, Medical College and Hospital, Department of Medical Oncology, Kolkata.

 

Other laboratories are National Institute for Research in Tuberculosis, Chennai, National Tuberculosis Institute, Bengaluru, Post Graduate Institute of Medical Education and Research, Chandigarh, Institute of Tuberculosis and Respiratory Diseases, New Delhi, National Jalma Institute of Leprosy and other Mycobacterial Diseases, Agra, Rajan Babu TB Hospital, Delhi, Shantabai Devarao Shivaram Tuberculosis Research Centre and Rajiv Gandhi lnstitute of Chest Diseases, Bengaluru, National Institute for Research in Tribal Health, Madhya Pradesh, National lnstitute of Malaria Research (ICMR), Delhi, Division of Clinical Microbiology & Molecular Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, National lnstitute of Cholera and Enteric Diseases, Kolkata, National lnstitute of Communicable Diseases (NICD), New Delhi, Sawai Man Singh Medical College, Rajasthan, Division of Genetics, Department of Paediatrics, Maulana Azad Medical College, New Delhi, Division of Genetics, Department of Paediatrics, AIIMS, New Delhi. Pharmabiz