The Central Drugs Standard Control Organization (CDSCO) has released a guidance list of laboratories that are authorized to provide performance evaluation reports for Class, B, Class C and Class D medical devices.
Medical devices for the following disease conditions require performance evaluation reports:
- Blood Grouping reagent
- Blood glucose test reagent
- 9. Dengue
- ToRCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus)
- Methicilline-Resistant Staphylococcus Aureus
- Entero virus
- Markers for congenital disorders e.g. Screen test for Down’s Syndrome
- Sexually transmitted agent i.e. Treponema pallidum, Neisseria gonorrhoeae,
- Human Papilloma Virus, Herpes Virus
- Other life threatening infections / agents
In addition to the 37 laboratories authorized for testing medical devices, the CDSCO has also approved the use of any other laboratory that is 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).
Read the complete list here.