(3) In case of imported diagnostic in vitro diagnostic medical devices, the report of evaluation in details conducted by the National Control Authority of country of origin. (4) Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter. (5) The detailed test report of all the components used / packed in the finished in vitro diagnostic medical device. (6) Pack size and labeling. (7) Product inserts. (8) Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the in vitro diagnostic medical device. (9) Specific processing like safe handling, material control, area control, process control, and stability studies, storage at quarantine stage and finished stage, packaging should be highlighted in the product dossier.