RE: India28 Apr 2021 07:11
"On similar lines, it is now proposed that real time RTPCR, RAT, home based testing solutions,
antigen/antibody ELISA/CLIA and rapid antibody tests approved by the following reputed global agencies
may also be exempted from validation in India and accorded marketing permission by DCGI on the basis of
existing approvals:
1. European CE/IVD
2. Ministry of Food and Drug Safety, Korea (formerly known as Korea Food & Drug Administration or KFDA)
3. Pharmaceuticals and Medical Devices Agency (PMDA), Japan
4. Therapeutic Goods Administration (TGA), Australia
5. Brazil ANVISA
6. WHO Emergency Use Listing (EUL) procedure"
Well spotted ,PL75. Our Elisa, for starters is just the best in the world and can certainly help their labs.