Mumbai, 17 Oct 2019: The Central Drugs Standard Control Organisation (CDSCO) has mandated Central and State licensing authorities to get performance evaluation reports (PERs) of 19 specified In-vitro Diagnostic (IVD) tests for grant of import and manufacturing licenses.
According to the a CDSCO notice, PERs have to be done on three batches of IVD tests with support from notified labs as per the new Medical Device (MD) Rules, 2017.
PERs mandated for IVD tests include HIV, HBV, HCV, blood grouping reagent, cancer, tuberculosis, malaria, dengue, chikunguia, syphlis, typhoid, infuenza, toxoplasma gondii, rubella virus, cytomegalovirus, herpes simplex virus (ToRCH), chlamydia, pneumonia, methioilllne resistant staphylococcus aureus (MRSA), entero virus, marker for congenital disorder for example screen test for Down’s syndrome, sexually transmitted agent i.e. Treponema pallidum, neisseria gonorrhoeae, human papillomavirus (HPV), herpes virus and other life threatening infections or agent.
In case of IVDs which are licensed and available in the Indian market for long time and manufactured in lesser number of batches per year, central and state licensing authorities should get PER from the lab for one batch to grant license. This is based on the condition that for the subsequent two consecutive batches, satisfactory PER should be submitted by the manufacturer to the concerned authority as and when it is manufactured.
If there is inability of lab or longer testing time etc., other options are available for testing like any central government or state government laboratory of any hospital or of any institute laboratory accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers (NABH) are also available as provided in the new MD Rules.
CDSCO had recently issued guidelines on performance evaluation of IVD medical devices for grant of manufacturing and import licenses as per new MD Rules, 2017 which is effective from January 1, 2018.
It also issued reference list of laboratories in the country for conducting performance evaluation of IVDs. It had directed notified laboratories to test and evaluate IVD medical devices and issue PERs for the purpose of grant of manufacturing and import licenses.
Import license is issued by CDSCO in India for an individual or industry having wholesale or manufacturing license for medical devices.