(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 de ...

Note: 1. All the test reports submitted as a part of the dossier should be signed and dated by the responsible person. 2. Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 consecutive batches should be submitted. 3. All certificates submitted must be within the validity period. 4. Any information which is not relevant for the subject in vitro diagnostic medic ...