Information required to be submitted for the in vitro diagnostic medical device: (1) The details of source antigen or antibody as the case may be and characterization of the same. Process control of coating of antigen or antibody on the base material like Nitrocellulose paper, strips or cards or ELISA wells etc. Detailed composition of the in vitro diagnostic medical device and manufacturing flow chart process of the in vitro diagnostic medical device showing the specific flow diagram of individual components or source of the individual components. (2) Test protocol of the in vitro diagnostic medical device showing the specifications and method of testing. In house evaluation report of sensitivity, specificity and stability studies carried out by the manufacturer. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (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.