Updated List of Laboratories for Performance Evaluation of IVDs

The Central Drugs Standard Control Organization (CDSCO) has published its updated list of laboratories for performance evaluation of IVDs. This notification is dated November 29, 2023.

Through this notification the CDSCO has published the names of testing facilities that will be permitted to carry out performance evaluation of various categories of In – Vitro Diagnostic Medical Devices.

The following are some categories of In vitro Diagnostics Medical Devices contemplated by this notification:

1. In-Vitro Diagnostic Reagents/ Kits for detection for HIV
2. In-Vitro Diagnostic Reagents/ Kits for detection for HBV
3. In-Vitro Diagnostic Reagents/ Kits for detection for HCV
4. In vitro Diagnostic Reagents/ Kits for Blood Grouping or Tissue Typing
5. In vitro Diagnostic Reagents/ Kits for detection of Cancer
6. In vitro Diagnostic Reagents/ Kits for Detection of Tuberculosis (TB)
7. In vitro Diagnostic Reagents/ Kits for Detection of Malaria
8. In vitro Diagnostic Reagents/ Kits for Detection of Dengue
9. In vitro Diagnostic Reagents/ Kits for Detection of Chikungunya
10. In vitro Diagnostic Reagents/ Kits for Detection of Treponema pallidum (Syphilis)
11. In vitro Diagnostic Reagents/ Kits for Detection of Typhoid

The above mentioned devices are not exhaustive. The notification references a total of 23 types of In vitro Diagnostics Medical Devices.