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 The Central Drugs Standard Control Organisation (CDSCO) has revised the list of laboratories conducting performance evaluation of In-Vitro Diagnostic (IVD) medical devices, enlisting Noida-based National Institute of Biologicals (NIB) to test IVD reagents and kits for detection of malaria.
The drug regulator has also added ICMR-National Institute of Cancer Prevention and Research, formerly Institute of Cytology and Preventive Oncology (ICPO), Noida, to test IVD reagents and kits for detection and typing of Human Papilloma Virus (HPV) infection.
Based on the revised list, the NIB has the regulator's consent to conduct performance evaluation of IVD reagents and kits for eight categories.
This, apart from the reagents or kits of IVD medical devices for the detection of Malaria, include devices for detection of HIV, HBV, HCV, Dengue, Treponema pallidum (Syphilis), SARS - CoV-2, and reagents and kits for Blood Grouping or Tissue Typing.
Apart from the performance evaluation of IVD reagents and kits for detection and typing of HPV infection, the ICMR-National Institute of Cancer Prevention and Research has already been approved for performance evaluation of IVD reagents and kits for detection of cancer.
The list details the laboratories assigned for testing of IVD medical devices for a total of 22 categories, including for testing of devices for HIV, HBV, HCV, cancer, tuberculosis, malaria, dengue, chikungunya, syphilis, typhoid, influenza, toxoplasma Gondii, rubella virus and cytomegalo virus, pneumonia, methicilline resistant staphylococcus aureus, entero virus (A/B), markers for congenital disorders, Neisseria Gonorrhoeae, human papilloma virus (HPV), sickle cell disease, and SARS-CoV-2.
According to the provisions under the Fourth Schedule of the Medical Devices Rules, 2017, which enlists the documents required for grant of licence to manufacture for sale or for distribution or import of medical devices, for IVD medical devices the manufacturer should submit a performance evaluation report (PER) for approval.
In a guidance document on the performance evaluation of IVD medical devices, the CDSCO has in 2018 said 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 (NABL) or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers (NABH) 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.
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