Given their important role in healthcare industry, in-vitro diagnostic devices (IVDs) have to be strictly regulated and monitored. CDSCO has formulated strict guidelines for IVDs in India. This apex regulatory body is aimed at enforcing these regulations to monitor the quality, efficacy, and safety of IVDs. Hence, compliance with Indian IVD regulations is mandatory for all devices entering the Indian market. IVD manufacturers and importers are expected to thoroughly evaluate the performance of their products per CDSCO requirements. To improve access to testing centres, CDSCO has published an updated list of laboratories for IVD performance evaluation. This is expected to speed up market approval time for IVDs.
Updated CDSCO approved laboratories for IVD performance evaluation
To streamline the regulatory approval workflow, CDSCO has listed a number of laboratories with specific scopes for IVD performance evaluation. This updated list will allow manufacturers to select laboratories based on the type of diagnostic kit they are developing. They can choose a suitable lab from a plethora of IVD performance evaluation labs available.
- Blood Grouping /Tissue Typing: 10 laboratories approved
- HIV Detection: 13 laboratories approved
- Hepatitis B (HBV): 13 laboratories approved
- Hepatitis C (HCV): 12 laboratories approved
- Cancer Biomarker Detection: 9 laboratories approved
- Tuberculosis (TB): 14 laboratories approved
- Chikungunya: 13 laboratories approved
- Malaria: 7 laboratories approved
- Dengue: 18 laboratories approved
- Treponema pallidum (Syphilis): 10 laboratories approved
- Typhoid: 7 laboratories approved
- Influenza: 13 laboratories approved
- Toxoplasma Gondii: 6 laboratories approved
- Methicillin-Resistant Staphylococcus Aureus (MRSA): 7 laboratories approved
- Enterovirus A/B: 5 laboratories approved
- Neisseria Gonorrhoeae: 9 laboratories approved
- Human Papilloma Virus (HPV) Typing: 6 laboratories approved
- Sickle Cell Detection: 5 laboratories approved
- Rubella Virus & Cytomegalovirus (CMV): 6 laboratories approved
- Pneumonia Pathogens: 5 laboratories approved
Updated laboratory list specific for COVID-19 IVD kits
India is witnessing a fresh wave of COVID-19. The number of cases is on the rise. Hence, SARS-CoV-2 diagnostic kits will be in high demand. In response to the renewed demand for these kits in the country, CDSCO has updated the list of approved laboratories for the evaluation of SARS-CoV-2 diagnostic kits, covering RT-PCR and RT-LAMP technologies. RT-PCR kits are the gold standard for COVID diagnostics. Hence, they are currently in high demand. The laboratories for IVD performance evaluation specifically for COVID-19 IVD diagnostic kits are as follows:
- National Institute of Biologicals (NIB), Uttar Pradesh, has been authorized for RT-PCR and RT-LAMP evaluation
- Virus Research and Diagnostic Laboratories (VRDLs) located in New Delhi, Assam, Telangana, Puducherry, Karnataka (2 labs) have also been approved.
These IVD performance evaluation facilities are well-equipped to thoroughly evaluate the COVID-19 detection kits.
Pharmadocx Consultants will help you easily launch your IVDs in the Indian market
IVDs have a crucial role in patient diagnosis. They are used to understand the current state of health to determine the course of treatment required. Furthermore, IVD devices are used for testing patients in the primary health care facilities where labs are not available. Hence, IVDs have an indispensable role in patient diagnosis and care. Thus, per CDSCO requirements, performance of IVDs has to be thoroughly evaluated. To fulfil this requirement, CDSCO has published an updated list of laboratories for IVD performance evaluation. These laboratories have been categorised based on their specific scope to help manufacturers choose laboratories according to their requirements. To easily navigate CDSCO regulations for IVDs, drop an email at [email protected] or call/Whatsapp on 9996859227.
