Guidelines on performance evaluation of IVDs for grant of manufacturing and import licenses issued by CDSCO

Guidelines on performance evaluation of IVDs for grant of manufacturing and import licenses issued by CDSCO

Guidelines has been issued by the Central Drugs Standard Control Organisation (CDSCO) for evaluation of performance of In-Vitro Diagnostic (IVD) medical devices for grant of manufacturing and import licenses as per new Medical Device (MD) Rules, 2017 working effectively from January 1, 2018.

Reference list of laboratories has also been issued in the country for the conduction of evaluation of performance of IVDs. Direction has been passed to the notified laboratories for testing and evaluating IVD medical devices and issuance of performance evaluation reports (PERs) for the purpose of grant of manufacturing and import licenses.

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

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